[107th Congress Public Law 250]
[From the U.S. Government Printing Office]
<DOC>
[DOCID: f:publ250.107]
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MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002
[[Page 116 STAT. 1588]]
Public Law 107-250
107th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act to make improvements
in the regulation of medical devices, and for other
purposes. <<NOTE: Oct. 26, 2002 - [H.R. 5651]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress <<NOTE: Medical Device User Fee and
Modernization Act of 2002.>> assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This <<NOTE: 21 USC 301 note.>> Act may be cited
as the ``Medical Device User Fee and Modernization Act of 2002''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--FEES RELATED TO MEDICAL DEVICES
Sec. 101. Findings.
Sec. 102. Establishment of program.
Sec. 103. Annual reports.
Sec. 104. Postmarket surveillance.
Sec. 105. Consultation.
Sec. 106. Effective date.
Sec. 107. Sunset clause.
TITLE II--AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES
Sec. 201. Inspections by accredited persons.
Sec. 202. Third party review of premarket notification.
Sec. 203. Debarment of accredited persons.
Sec. 204. Designation and regulation of combination products.
Sec. 205. Report on certain devices.
Sec. 206. Electronic labeling.
Sec. 207. Electronic registration.
Sec. 208. Intended use.
Sec. 209. Modular review.
Sec. 210. Pediatric expertise regarding classification-panel review of
premarket applications.
Sec. 211. Internet list of class II devices exempted from requirement of
premarket notification.
Sec. 212. Study by Institute of Medicine of postmarket surveillance
regarding pediatric populations.
Sec. 213. Guidance regarding pediatric devices.
Sec. 214. Breast implants; study by Comptroller General.
Sec. 215. Breast implants; research through National Institutes of
Health.
TITLE III--ADDITIONAL AMENDMENTS
Sec. 301. Identification of manufacturer of medical devices.
Sec. 302. Single-use medical devices.
Sec. 303. MedWatch.
[[Page 116 STAT. 1589]]
TITLE I--FEES RELATED TO MEDICAL DEVICES
SEC. 101. <<NOTE: 21 USC 379i note.>> FINDINGS.
The Congress finds that--
(1) prompt approval and clearance of safe and effective
devices is critical to the improvement of the public health so
that patients may enjoy the benefits of devices to diagnose,
treat, and prevent disease;
(2) the public health will be served by making additional
funds available for the purpose of augmenting the resources of
the Food and Drug Administration that are devoted to the process
for the review of devices and the assurance of device safety and
effectiveness so that statutorily mandated deadlines may be met;
and
(3) the fees authorized by this title will be dedicated to
meeting the goals identified in the letters from the Secretary
of Health and Human Services to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate, as set
forth in the Congressional Record.
SEC. 102. ESTABLISHMENT OF PROGRAM.
(a) In General.--Subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379F et seq.) is amended by adding at
the end the following part:
``PART 3--FEES RELATING TO DEVICES
``SEC. 737. <<NOTE: 21 USC 379i.>> DEFINITIONS.
``For purposes of this subchapter:
``(1) The term `premarket application' means--
``(A) an application for approval of a device
submitted under section 515(c) or section 351 of the
Public Health Service Act; or
``(B) a product development protocol described in
section 515(f).
Such term does not include a supplement, a premarket report, or
a premarket notification submission.
``(2) The term `premarket report' means a report submitted
under section 515(c)(2).
``(3) The term `premarket notification submission' means a
report submitted under section 510(k).
``(4)(A) The term `supplement', with respect to a panel-
track supplement, a 180-day supplement, a real-time supplement,
or an efficacy supplement, means a request to the Secretary to
approve a change in a device for which--
``(i) an application or report has been approved
under section 515(d), or an application has been
approved under section 351 of the Public Health Service
Act; or
``(ii) a notice of completion has become effective
under section 515(f).
``(B) The term `panel-track supplement' means a supplement
to an approved premarket application or premarket report under
section 515 that requests a significant change in design or
performance of the device, or a new indication for use of
[[Page 116 STAT. 1590]]
the device, and for which clinical data are generally necessary
to provide a reasonable assurance of safety and effectiveness.
``(C) The term `180-day supplement' means a supplement to an
approved premarket application or premarket report under section
515 that is not a panel-track supplement and requests a
significant change in components, materials, design,
specification, software, color additives, or labeling.
``(D) The term `real-time supplement' means a supplement to
an approved premarket application or premarket report under
section 515 that requests a minor change to the device, such as
a minor change to the design of the device, software,
manufacturing, sterilization, or labeling, and for which the
applicant has requested and the agency has granted a meeting or
similar forum to jointly review and determine the status of the
supplement.
``(E) The term `efficacy supplement' means a supplement to
an approved premarket application under section 351 of the
Public Health Service Act that requires substantive clinical
data.
``(5) The term `process for the review of device
applications' means the following activities of the Secretary
with respect to the review of premarket applications, premarket
reports, supplements, and premarket notification submissions:
``(A) The activities necessary for the review of
premarket applications, premarket reports, supplements,
and premarket notification submissions.
``(B) The issuance of action letters that allow the
marketing of devices or which set forth in detail the
specific deficiencies in such applications, reports,
supplements, or submissions and, where appropriate, the
actions necessary to place them in condition for
approval.
``(C) The inspection of manufacturing establishments
and other facilities undertaken as part of the
Secretary's review of pending premarket applications,
premarket reports, and supplements.
``(D) Monitoring of research conducted in connection
with the review of such applications, reports,
supplements, and submissions.
``(E) Review of device applications subject to
section 351 of the Public Health Service Act for an
investigational new drug application under section
505(i) or for an investigational device exemption under
section 520(g) and activities conducted in anticipation
of the submission of such applications under section
505(i) or 520(g).
``(F) The development of guidance, policy documents,
or regulations to improve the process for the review of
premarket applications, premarket reports, supplements,
and premarket notification submissions.
``(G) The development of voluntary test methods,
consensus standards, or mandatory performance standards
under section 514 in connection with the review of such
applications, reports, supplements, or submissions and
related activities.
``(H) The provision of technical assistance to
device manufacturers in connection with the submission
of such applications, reports, supplements, or
submissions.
[[Page 116 STAT. 1591]]
``(I) Any activity undertaken under section 513 or
515(i) in connection with the initial classification or
reclassification of a device or under section 515(b) in
connection with any requirement for approval of a
device.
``(J) Evaluation of postmarket studies required as a
condition of an approval of a premarket application
under section 515 or section 351 of the Public Health
Service Act.
``(K) Compiling, developing, and reviewing
information on relevant devices to identify safety and
effectiveness issues for devices subject to premarket
applications, premarket reports, supplements, or
premarket notification submissions.
``(6) The term `costs of resources allocated for the process
for the review of device applications' means the expenses
incurred in connection with the process for the review of device
applications for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related
to such officers, employees, and committees and to
contracts with such contractors;
``(B) management of information, and the
acquisition, maintenance, and repair of computer
resources;
``(C) leasing, maintenance, renovation, and repair
of facilities and acquisition, maintenance, and repair
of fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees and accounting for resources
allocated for the review of premarket applications,
premarket reports, supplements, and submissions.
``(7) The term `adjustment factor' applicable to a fiscal
year is the Consumer Price Index for all urban consumers (all
items; United States city average) for April of the preceding
fiscal year divided by such Index for April 2002.
``(8) The term `affiliate' means a business entity that has
a relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power
to control, the other business entity; or
``(B) a third party controls, or has power to
control, both of the business entities.
``SEC. 738. <<NOTE: 21 USC 379j.>> AUTHORITY TO ASSESS AND USE DEVICE
FEES.
``(a) Types of Fees.--Beginning on the date of the enactment of the
Medical Device User Fee and Modernization Act of 2002, the Secretary
shall assess and collect fees in accordance with this section as
follows:
``(1) Premarket application, premarket report, supplement,
and submission fee.--
``(A) In general.--Except as provided in
subparagraph (B) and subsection (d), each person who
submits any of the following, on or after October 1,
2002, shall be subject to a fee established under
subsection (c)(5) for the fiscal year involved in
accordance with the following:
``(i) A premarket application.
[[Page 116 STAT. 1592]]
``(ii) For a premarket report, a fee equal to
the fee that applies under clause (i).
``(iii) For a panel track supplement, a fee
equal to the fee that applies under clause (i).
``(iv) For a 180-day supplement, a fee equal
to 21.5 percent of the fee that applies under
clause (i), subject to any adjustment under
subsection (c)(3).
``(v) For a real-time supplement, a fee equal
to 7.2 percent of the fee that applies under
clause (i).
``(vi) For an efficacy supplement, a fee equal
to the fee that applies under clause (i).
``(vii) For a premarket notification
submission, a fee equal to 1.42 percent of the fee
that applies under clause (i), subject to any
adjustment under subsection (c)(3) and any
adjustment under subsection (e)(2)(C)(ii).
``(B) Exceptions.--
``(i) Humanitarian device exemption.--An
application under section 520(m) is not subject to
any fee under subparagraph (A).
``(ii) Further manufacturing use.--No fee
shall be required under subparagraph (A) for the
submission of a premarket application under
section 351 of the Public Health Service Act for a
product licensed for further manufacturing use
only.
``(iii) State or federal government
sponsors.--No fee shall be required under
subparagraph (A) for a premarket application,
premarket report, supplement, or premarket
notification submission submitted by a State or
Federal Government entity unless the device
involved is to be distributed commercially.
``(iv) Premarket notifications by third
parties.--No fee shall be required under
subparagraph (A) for a premarket notification
submission reviewed by an accredited person
pursuant to section 523.
``(v) Pediatric conditions of use.--
``(I) In general.--No fee shall be
required under subparagraph (A) for a
premarket application, premarket report,
or premarket notification submission if
the proposed conditions of use for the
device involved are solely for a
pediatric population. No fee shall be
required under such subparagraph for a
supplement if the sole purpose of the
supplement is to propose conditions of
use for a pediatric population.
``(II) Subsequent proposal of adult
conditions of use.--In the case of a
person who submits a premarket
application or premarket report for
which, under subclause (I), a fee under
subparagraph (A) is not required, any
supplement to such application that
proposes conditions of use for any adult
population is subject to the fee that
applies under such subparagraph for a
premarket application.
``(C) Payment.--The fee required by subparagraph (A)
shall be due upon submission of the premarket
application, premarket report, supplement, or premarket
notification submission except that invoices for
applications submitted
[[Page 116 STAT. 1593]]
between October 1, 2002, and the date of the enactment
of the Medical Device User Fee and Modernization Act of
2002 shall be payable on October 30, 2002. Applicants
submitting portions of applications pursuant to section
515(c)(3) shall pay such fees upon submission of the
first portion of such applications. The fees credited to
fiscal year 2003 under this section shall include all
fees payable from October 1, 2002, through September 30,
2003.
``(D) Refunds.--
``(i) Application refused for filing.--The
Secretary shall refund 75 percent of the fee paid
under subparagraph (A) for any application or
supplement that is refused for filing.
``(ii) Application withdrawn before filing.--
The Secretary shall refund 75 percent of the fee
paid under subparagraph (A) for any application or
supplement that is withdrawn prior to the filing
decision of the Secretary.
``(iii) Application withdrawn before first
action.--After receipt of a request for a refund
of the fee paid under subparagraph (A) for a
premarket application, premarket report, or
supplement that is withdrawn after filing but
before a first action, the Secretary may return
some or all of the fee. The amount of refund, if
any, shall be based on the level of effort already
expended on the review of such application,
report, or supplement. The Secretary shall have
sole discretion to refund a fee or portion of the
fee under this subparagraph. A determination by
the Secretary concerning a refund under this
paragraph shall not be reviewable.
``(b) Fee Revenue Amounts.--Except as provided in subsections (c),
(d), (e), (g), and (h), the fees under subsection (a) shall be
established to generate the following revenue amounts: $25,125,000 in
fiscal year 2003; $27,255,000 in fiscal year 2004; $29,785,000 in fiscal
year 2005; $32,615,000 in fiscal year 2006, and $35,000,000 in fiscal
year 2007. If legislation is enacted after the date of the enactment of
the Medical Device User Fee and Modernization Act of 2002 requiring the
Secretary to fund additional costs of the retirement of Federal
personnel, fee revenue amounts under this subsection shall be increased
in each year by the amount necessary to fully fund the portion of such
additional costs that are attributable to the process for the review of
device applications.
``(c) Adjustments.--
``(1) Inflation adjustment.--The <<NOTE: Federal Register,
publication.>> revenues established in subsection (b) shall be
adjusted by the Secretary by notice, published in the Federal
Register, for a fiscal year to reflect the greater of--
``(A) the total percentage change that occurred in
the Consumer Price Index for all urban consumers (all
items; U.S. city average) for the 12 month period ending
June 30 preceding the fiscal year for which fees are
being established, or
``(B) the total percentage change for the previous
fiscal year in basic pay under the General Schedule in
accordance with section 5332 of title 5, United States
Code, as adjusted
[[Page 116 STAT. 1594]]
by any locality-based comparability payment pursuant to
section 5304 of such title for Federal employees
stationed in the District of Columbia.
The adjustment made each fiscal year by this subsection shall be
added on a compounded basis to the sum of all adjustments made
each fiscal year after fiscal year 2003 under this subsection.
``(2) Workload adjustment.--After the fee revenues
established in subsection (b) are adjusted for a fiscal year for
inflation in accordance with paragraph (1), the fee revenues
shall, beginning with fiscal year 2004, be adjusted further each
fiscal year to reflect changes in the workload of the Secretary
for the process for the review of device applications. With
respect to such adjustment:
``(A) The adjustment shall be determined by the
Secretary based on a weighted average of the change in
the total number of premarket applications,
investigational new device applications, premarket
reports, supplements, and premarket notification
submissions submitted to the Secretary. <<NOTE: Federal
Register, publication.>> The Secretary shall publish in
the Federal Register the fee revenues and fees resulting
from the adjustment and the supporting methodologies.
``(B) Under no circumstances shall the adjustment
result in fee revenues for a fiscal year that are less
than the fee revenues for the fiscal year established in
subsection (b), as adjusted for inflation under
paragraph (1).
``(3) Compensating adjustment.--After the fee revenues
established in subsection (b) are adjusted for a fiscal year for
inflation in accordance with paragraph (1), and for workload in
accordance with paragraph (2), the fee revenues shall, beginning
with fiscal year 2004, be adjusted further each fiscal year, if
necessary, to reflect the cumulative amount by which collections
for previous fiscal years, beginning with fiscal year 2003, fell
below the cumulative revenue amounts for such fiscal years
specified in subsection (b), adjusted for such fiscal years for
inflation in accordance with paragraph (1), and for workload in
accordance with paragraph (2).
``(4) Final year adjustment.--For fiscal year 2007, the
Secretary may, in addition to adjustments under paragraphs (1)
and (2), further increase the fees and fee revenues established
in subsection (b) if such adjustment is necessary to provide for
not more than three months of operating reserves of carryover
user fees for the process for the review of device applications
for the first three months of fiscal year 2008. If such an
adjustment is necessary, the rationale for the amount of the
increase shall be contained in the annual notice establishing
fee revenues and fees for fiscal year 2007. If the Secretary has
carryover user fee balances for such process in excess of three
months of such operating reserves, the adjustment under this
paragraph shall not be made.
``(5) Annual fee setting.--The <<NOTE: Federal Register,
publication.>> Secretary shall, 60 days before the start of each
fiscal year after September 30, 2002, establish, for the next
fiscal year, and publish in the Federal Register, fees under
subsection (a), based on the revenue amounts established under
subsection (b) and the adjustment provided under this subsection
and subsection (e)(2)(C)(ii),
[[Page 116 STAT. 1595]]
except that the fees established for fiscal year 2003 shall be
based on a premarket application fee of $154,000.
``(6) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated for
the process for the review of device applications.
``(d) Small Businesses; Fee Waiver and Fee Reduction Regarding
Premarket Approval Fees.--
``(1) In general.--The Secretary shall grant a waiver of the
fee required under subsection (a) for one premarket application,
or one premarket report, where the Secretary finds that the
applicant involved is a small business submitting its first
premarket application to the Secretary, or its first premarket
report, respectively, for review. In addition, for subsequent
premarket applications, premarket reports, and supplements where
the Secretary finds that the applicant involved is a small
business, the fees specified in clauses (i) through (vi) of
subsection (a)(1)(A) may be paid at a reduced rate in accordance
with paragraph (2)(C).
``(2) Rules relating to premarket approval fees.--
``(A) Definition.--
``(i) In general.--For purposes of this
subsection, the term `small business' means an
entity that reported $30,000,000 or less of gross
receipts or sales in its most recent Federal
income tax return for a taxable year, including
such returns of all of its affiliates, partners,
and parent firms.
``(ii) Adjustment.--The Secretary may adjust
the $30,000,000 threshold established in clause
(i) if the Secretary has evidence from actual
experience that this threshold results in a
reduction in revenues from premarket applications,
premarket reports, and supplements that is 16
percent or more than would occur without small
business exemptions and lower fee rates. To
adjust <<NOTE: Federal Register,
publication. Notice.>> this threshold, the
Secretary shall publish a notice in the Federal
Register setting out the rationale for the
adjustment, and the new threshold.
``(B) Evidence of qualification.--An applicant shall
pay the higher fees established by the Secretary each
year unless the applicant submits evidence that it
qualifies for a waiver of the fee or the lower fee rate.
The applicant shall support its claim that it meets the
definition under subparagraph (A) by submission of a
copy of its most recent Federal income tax return for a
taxable year, and a copy of such returns of its
affiliates, partners, and parent firms. which show an
amount of gross sales or receipts that is less than the
maximum established in subparagraph (A). The applicant,
and each of such affiliates, partners, and parent firms,
shall certify that the information provided is a true
and accurate copy of the actual tax forms they submitted
to the Internal Revenue Service. If no tax forms are
submitted for affiliates, partners, or parent firms, the
applicant shall certify that the applicant has no
affiliates, partners, or parent firms, respectively.
``(C) Reduced fees.--Where the Secretary finds that
the applicant involved meets the definition under
subparagraph (A), the fees established under subsection
(c)(5) may
[[Page 116 STAT. 1596]]
be paid at a reduced rate of 38 percent of the fee
established under such subsection for a premarket
application, a premarket report, or a supplement.
``(D) Request for fee waiver or reduction.--An
applicant seeking a fee waiver or reduction under this
subsection shall submit supporting information to the
Secretary at least 60 days before the fee is required
pursuant to subsection (a). The decision of the
Secretary regarding whether an entity qualifies for such
a waiver or reduction is not reviewable.
``(e) Small Businesses; Fee Reduction Regarding Premarket
Notification Submissions.--
``(1) In general.--Where the Secretary finds that the
applicant involved is a small business, the fee specified in
subsection (a)(1)(A)(vii) may be paid at a reduced rate in
accordance with paragraph (2)(C).
``(2) Rules relating to premarket notification
submissions.--
``(A) Definition.--For purposes of this subsection,
the term `small business' means an entity that reported
$30,000,000 or less of gross receipts or sales in its
most recent Federal income tax return for a taxable
year, including such returns of all of its affiliates,
partners, and parent firms.
``(B) Evidence of qualification.--An applicant shall
pay the higher fees established by the Secretary each
year unless the applicant submits evidence that it
qualifies for the lower fee rate. The applicant shall
support its claim that it meets the definition under
subparagraph (A) by submission of a copy of its most
recent Federal income tax return for a taxable year, and
a copy of such returns of its affiliates, partners, and
parent firms. which show an amount of gross sales or
receipts that is less than the maximum established in
subparagraph (A). The applicant, and each of such
affiliates, partners, and parent firms, shall certify
that the information provided is a true and accurate
copy of the actual tax forms they submitted to the
Internal Revenue Service. If no tax forms are submitted
for affiliates, partners, or parent firms, the applicant
shall certify that the applicant has no affiliates,
partners, or parent firms, respectively.
``(C) Reduced fees.--
``(i) In general.--Where the Secretary finds
that the applicant involved meets the definition
under subparagraph (A), the fee for a premarket
notification submission may be paid at 80 percent
of the fee that applies under subsection
(a)(1)(A)(vii), as adjusted under clause (ii) and
as established under subsection (c)(5).
``(ii) Adjustment per fee revenue amount.--For
fiscal year 2004 and each subsequent fiscal year,
the Secretary, in setting the revenue amount under
subsection (c)(5) for premarket notification
submissions, shall determine the revenue amount
that would apply if all such submissions for the
fiscal year involved paid a fee equal to 1.42
percent of the amount that applies under
subsection (a)(1)(A)(i) for premarket
[[Page 116 STAT. 1597]]
applications, and shall adjust the fee under
subsection (a)(1)(A)(vii) for premarket
notification submissions such that the reduced
fees collected under clause (i) of this
subparagraph, when added to fees for such
submissions that are not paid at the reduced rate,
will equal such revenue amount for the fiscal
year.
``(D) Request for reduction.--An applicant seeking a
fee reduction under this subsection shall submit
supporting information to the Secretary at least 60 days
before the fee is required pursuant to subsection (a).
The decision of the Secretary regarding whether an
entity qualifies for such a reduction is not reviewable.
``(f) Effect of Failure to Pay Fees.--A premarket application,
premarket report, supplement, or premarket notification submission
submitted by a person subject to fees under subsection (a) shall be
considered incomplete and shall not be accepted for filing by the
Secretary until all fees owed by such person have been paid.
``(g) Conditions.--
``(1) Performance goals through fiscal year 2005;
termination of program after fiscal year 2005.--With respect to
the amount that, under the salaries and expenses account of the
Food and Drug Administration, is appropriated for a fiscal year
for devices and radiological products:
``(A)(i) For each of the fiscal years 2003 and 2004,
the Secretary is expected to meet all of the goals
identified for the fiscal year involved in any letter
referred to in section 101(3) of the Medical Device User
Fee and Modernization Act of 2002 (referred to in this
paragraph as `performance goals') if the amount so
appropriated for such fiscal year, excluding the amount
of fees appropriated for such fiscal year, is equal to
or greater than $205,720,000 multiplied by the
adjustment factor applicable to the fiscal year.
``(ii) For each of the fiscal years 2003 and 2004,
if the amount so appropriated for the fiscal year
involved, excluding the amount of fees appropriated for
such fiscal year, is less than the amount that applies
under clause (i) for such fiscal year, the following
applies:
``(I) The Secretary is expected to meet such
goals to the extent practicable, taking into
account the amounts that are available to the
Secretary for such purpose, whether from fees
under subsection (a) or otherwise.
``(II) <<NOTE: Reports.>> The Comptroller
General of the United States shall submit to the
Congress a report describing whether and to what
extent the Secretary is meeting the performance
goals identified for such fiscal year, and whether
the Secretary will be able to meet all performance
goals identified for <<NOTE: Deadline.>> fiscal
year 2005. A report under the preceding sentence
shall be submitted to the Congress not later than
July 1 of the fiscal year with which the report is
concerned.
``(B)(i) For fiscal year 2005, the Secretary is
expected to meet all of the performance goals identified
for the fiscal year if the total of the amounts so
appropriated for fiscal years 2003 through 2005,
excluding the amount
[[Page 116 STAT. 1598]]
of fees appropriated for such fiscal years, is equal to
or greater than the sum of--
``(I) $205,720,000 multiplied by the
adjustment factor applicable to fiscal year 2003;
``(II) $205,720,000 multiplied by the
adjustment factor applicable to fiscal year 2004;
and
``(III) $205,720,000 multiplied by the
adjustment factor applicable to fiscal year 2005.
``(ii) For fiscal year 2005, if the total of the
amounts so appropriated for fiscal years 2003 through
2005, excluding the amount of fees appropriated for such
fiscal years, is less than the sum that applies under
clause (i) for fiscal year 2005, the following applies:
``(I) The Secretary is expected to meet such
goals to the extent practicable, taking into
account the amounts that are available to the
Secretary for such purpose, whether from fees
under subsection (a) or otherwise.
``(II) <<NOTE: Reports.>> The Comptroller
General of the United States shall submit to the
Congress a report describing whether and to what
extent the Secretary is meeting the performance
goals identified for such fiscal year, and whether
the Secretary will be able to meet all performance
goals identified for <<NOTE: Deadline.>> fiscal
year 2006. The report under the preceding sentence
shall be submitted to the Congress not later than
July 1, 2005.
``(C) For fiscal year 2006, fees may not be assessed
under subsection (a) for the fiscal year, and the
Secretary is not expected to meet any performance goals
identified for the fiscal year, if the total of the
amounts so appropriated for fiscal years 2003 through
2006, excluding the amount of fees appropriated for such
fiscal years, is less than the sum of--
``(i) $205,720,000 multiplied by the
adjustment factor applicable to fiscal year 2006;
and
``(ii) an amount equal to the sum that applies
for purposes of subparagraph (B)(i).
``(D) For fiscal year 2007, fees may not be assessed
under subsection (a) for the fiscal year, and the
Secretary is not expected to meet any performance goals
identified for the fiscal year, if--
``(i) the amount so appropriated for the
fiscal year, excluding the amount of fees
appropriated for the fiscal year, is less than
$205,720,000 multiplied by the adjustment factor
applicable to fiscal year 2007; or
``(ii) pursuant to subparagraph (C), fees were
not assessed under subsection (a) for fiscal year
2006.
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year because
of subparagraph (C) or (D) of paragraph (1) and if at a later
date in such fiscal year the Secretary may assess such fees, the
Secretary may assess and collect such fees, without any
modification in the rate for premarket applications,
supplements, premarket reports, and premarket notification
submissions, and at any time in such fiscal year,
notwithstanding the provisions of subsection (a) relating to the
date fees are to be paid.
[[Page 116 STAT. 1599]]
``(h) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriation
Acts. Such fees are authorized to be appropriated to remain
available until expended. Such sums as may be necessary may be
transferred from the Food and Drug Administration salaries and
expenses appropriation account without fiscal year limitation to
such appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be available
solely for the process for the review of device applications.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this
section--
``(i) shall be retained in each fiscal year in
an amount not to exceed the amount specified in
appropriation Acts, or otherwise made available
for obligation, for such fiscal year, and
``(ii) shall only be collected and available
to defray increases in the costs of the resources
allocated for the process for the review of device
applications (including increases in such costs
for an additional number of full-time equivalent
positions in the Department of Health and Human
Services to be engaged in such process) over such
costs, excluding costs paid from fees collected
under this section, for fiscal year 2002
multiplied by the adjustment factor.
``(B) Compliance.--The Secretary shall be considered
to have met the requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by appropriations
and allocated for the process for the review of device
applications--
``(i) are not more than 3 percent below the
level specified in subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent below the
level specified in subparagraph (A)(ii), and fees
assessed for a subsequent fiscal year are
decreased by the amount in excess of 3 percent by
which such costs fell below the level specified in
such subparagraph; and
``(II) such costs are not more than 5 percent
below the level specified in such subparagraph.
``(3) Authorization of appropriations.--There are authorized
to be appropriated for fees under this section--
``(A) $25,125,000 for fiscal year 2003;
``(B) $27,255,000 for fiscal year 2004;
``(C) $29,785,000 for fiscal year 2005;
``(D) $32,615,000 for fiscal year 2006; and
``(E) $35,000,000 for fiscal year 2007,
as adjusted to reflect adjustments in the total fee revenues
made under this section and changes in the total amounts
collected by application fees.
``(4) Offset.--Any amount of fees collected for a fiscal
year under this section that exceeds the amount of fees
specified in appropriation Acts for such fiscal year shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted
[[Page 116 STAT. 1600]]
from the amount of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation Acts for
a subsequent fiscal year.
``(i) Collection of Unpaid Fees.--In <<NOTE: Deadline.>> any case
where the Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall be treated
as a claim of the United States Government subject to subchapter II of
chapter 37 of title 31, United States Code.
``(j) Written Requests for Refunds.--To <<NOTE: Deadline.>> qualify
for consideration for a refund under subsection (a)(1)(D), a person
shall submit to the Secretary a written request for such refund not
later than 180 days after such fee is due.
``(k) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in the process of the review of device
applications, be reduced to offset the number of officers, employees,
and advisory committees so engaged.''.
(b) Fee <<NOTE: 21 USC 379j note.>> Exemption for Certain Entities
Submitting Premarket Reports.--
(1) In general.--A person submitting a premarket report to
the Secretary of Health and Human Services is exempt from the
fee under section 738(a)(1)(A)(ii) of the Federal Food, Drug,
and Cosmetic Act (as added by subsection (a) of this section)
if--
(A) the premarket report is the first such report
submitted to the Secretary by the person; and
(B) before October 1, 2002, the person submitted a
premarket application to the Secretary for the same
device as the device for which the person is submitting
the premarket report.
(2) Definitions.--For purposes of paragraph (1), the terms
``device'', ``premarket application'', and ``premarket report''
have the same meanings as apply to such terms for purposes of
section 738 of the Federal Food, Drug, and Cosmetic Act (as
added by subsection (a) of this section).
SEC. 103. <<NOTE: 21 USC 379i note.>> ANNUAL REPORTS.
Beginning with fiscal year 2003, the Secretary shall prepare and
submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor and
Pensions of the Senate a report concerning--
(1) the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
section 101(3) during such fiscal year and the future plans of
the Food and Drug Administration for meeting the goals, not
later than 60 days after the end of each fiscal year during
which fees are collected under this part; and
(2) <<NOTE: Deadline.>> the implementation of the authority
for such fees during such fiscal year, and the use, by the Food
and Drug Administration, of the fees collected during such
fiscal year, not later than 120 days after the end of each
fiscal year during which fees are collected under the medical
device user-fee program established under the amendment made by
section 102.
SEC. 104. POSTMARKET SURVEILLANCE.
(a) Additional Authorization of Appropriations.--For the purpose of
carrying out postmarket surveillance of medical devices,
[[Page 116 STAT. 1601]]
there are authorized to be appropriated to the Food and Drug
Administration the following amounts, stated as increases above the
amount obligated for such purpose by such Administration for fiscal year
2002:
(1) For fiscal year 2003, an increase of $3,000,000.
(2) For fiscal year 2004, an increase of $6,000,000.
(3) For fiscal year 2005 and each subsequent fiscal year, an
increase of such sums as may be necessary.
(b) <<NOTE: 21 USC 379i note.>> Study.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall conduct
a study for the purpose of determining the following with
respect to the medical device user-fee program established under
the amendment made by section 102:
(A) The impact of such program on the ability of the
Food and Drug Administration to conduct postmarket
surveillance on medical devices.
(B) The programmatic improvements, if any, needed
for adequate postmarket surveillance of medical devices.
(C) The amount of funds needed to conduct adequate
postmarket surveillance of medical devices.
(D) The extent to which device companies comply with
the postmarket surveillance requirements, including
postmarket study commitments.
(E) The recommendations of the Secretary as to
whether, and in what amounts, user fees collected under
such user-fee program should be dedicated to postmarket
surveillance if the program is extended beyond fiscal
year 2007.
(2) Report.--Not <<NOTE: Deadline.>> later than January 10,
2007, the Secretary shall submit to the Committee on Energy and
Commerce of the House of Representatives, and the Committee on
Health, Education, Labor, and Pensions of the Senate, a report
that describes the findings of the study under paragraph (1).
SEC. 105. <<NOTE: 21 USC 379i note.>> CONSULTATION.
(a) In General.--In developing recommendations to the Congress for
the goals and plans for meeting the goals for the process for the review
of medical device applications for fiscal years after fiscal year 2007,
and for the reauthorization of sections 737 and 738 of the Federal Food,
Drug, and Cosmetic Act, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall consult with
the Committee on Energy and Commerce of the House of Representatives,
the Committee on Health, Education, Labor, and Pensions of the Senate,
appropriate scientific and academic experts, health care professionals,
representatives of patient and consumer advocacy groups, and the
regulated industry.
(b) Recommendations.--The <<NOTE: Federal Register,
publication.>> Secretary shall publish in the Federal Register
recommendations under subsection (a), after negotiations with the
regulated industry; shall present such recommendations to the
congressional committees specified in such paragraph; shall hold a
meeting at which the public may present its views on such
recommendations; and shall provide for a period of 30 days for the
public to provide written comments on such recommendations.
[[Page 116 STAT. 1602]]
SEC. 106. <<NOTE: 21 USC 379i note.>> EFFECTIVE DATE.
The amendments made by this title shall take effect on the date of
the enactment of this Act, except that fees shall be assessed for all
premarket applications, premarket reports, supplements, and premarket
notification submissions received on or after October 1, 2002,
regardless of the date of enactment.
SEC. 107. <<NOTE: 21 USC 379i note.>> SUNSET CLAUSE.
The amendments made by this title cease to be effective October 1,
2007, except that section 103 with respect to annual reports ceases to
be effective January 31, 2008.
TITLE II--AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES
SEC. 201. INSPECTIONS BY ACCREDITED PERSONS.
(a) In General.--Section 704 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374) is amended by adding at the end the following
subsection:
``(g)(1) <<NOTE: Deadline.>> Not later than one year after the date
of the enactment of this subsection, the Secretary shall, subject to the
provisions of this subsection, accredit persons for the purpose of
conducting inspections of establishments that manufacture, prepare,
propagate, compound, or process class II or class III devices that are
required in section 510(h), or inspections of such establishments
required to register pursuant to section 510(i). The owner or operator
of such an establishment that is eligible under paragraph (6) may, from
the list published under paragraph (4), select an accredited person to
conduct such inspections.
``(2) <<NOTE: Deadline. Federal Register, publication.>> Not later
than 180 days after the date of enactment of this subsection, the
Secretary shall publish in the Federal Register criteria to accredit or
deny accreditation to persons who request to perform the duties
specified in paragraph (1). Thereafter, the Secretary shall inform those
requesting accreditation, within 60 days after the receipt of such
request, whether the request for accreditation is adequate for review,
and the Secretary shall promptly act on the request for accreditation.
Any resulting accreditation shall state that such person is accredited
to conduct inspections at device establishments identified in paragraph
(1). The accreditation of such person shall specify the particular
activities under this subsection for which such person is accredited. In
the first year following the publication in the Federal Register of
criteria to accredit or deny accreditation to persons who request to
perform the duties specified in paragraph (1), the Secretary shall
accredit no more than 15 persons who request to perform duties specified
in paragraph (1).
``(3) An accredited person shall, at a minimum, meet the following
requirements:
``(A) Such person may not be an employee of the Federal
Government.
``(B) Such person shall be an independent organization which
is not owned or controlled by a manufacturer, supplier, or
vendor of articles regulated under this Act and which has no
organizational, material, or financial affiliation (including a
consultative affiliation) with such a manufacturer, supplier, or
vendor.
[[Page 116 STAT. 1603]]
``(C) Such person shall be a legally constituted entity
permitted to conduct the activities for which it seeks
accreditation.
``(D) Such person shall not engage in the design,
manufacture, promotion, or sale of articles regulated under this
Act.
``(E) The operations of such person shall be in accordance
with generally accepted professional and ethical business
practices, and such person shall agree in writing that at a
minimum the person will--
``(i) certify that reported information accurately
reflects data reviewed, inspection observations made,
other matters that relate to or may influence compliance
with this Act, and recommendations made during an
inspection or at an inspection's closing meeting;
``(ii) limit work to that for which competence and
capacity are available;
``(iii) treat information received, records,
reports, and recommendations as confidential commercial
or financial information or trade secret information,
except such information may be made available to the
Secretary;
``(iv) promptly respond and attempt to resolve
complaints regarding its activities for which it is
accredited; and
``(v) protect against the use, in carrying out
paragraph (1), of any officer or employee of the
accredited person who has a financial conflict of
interest regarding any product regulated under this Act,
and annually make available to the public disclosures of
the extent to which the accredited person, and the
officers and employees of the person, have maintained
compliance with requirements under this clause relating
to financial conflicts of interest.
``(4) <<NOTE: Publication.>> The Secretary shall publish on the
Internet site of the Food and Drug Administration a list of persons who
are accredited under paragraph (2). Such list shall be updated to ensure
that the identity of each accredited person, and the particular
activities for which the person is accredited, is known
to <<NOTE: Deadline.>> the public. The updating of such list shall be no
later than one month after the accreditation of a person under this
subsection or the suspension or withdrawal of accreditation, or the
modification of the particular activities for which the person is
accredited.
``(5)(A) To ensure that persons accredited under this subsection
continue to meet the standards of accreditation, the Secretary shall (i)
audit the performance of such persons on a periodic basis through the
review of inspection reports and inspections by persons designated by
the Secretary to evaluate the compliance status of a device
establishment and the performance of accredited persons, and (ii) take
such additional measures as the Secretary determines to be appropriate.
``(B) The Secretary may withdraw accreditation of any person
accredited under paragraph (2), after providing notice and an
opportunity for an informal hearing, when such person is substantially
not in compliance with the standards of accreditation, or poses a threat
to public health or fails to act in a manner that is consistent with the
purposes of this subsection. The Secretary may suspend the accreditation
of such person during the pendency of the process under the preceding
sentence.
[[Page 116 STAT. 1604]]
``(6)(A) Subject to subparagraphs (B) and (C), a device
establishment is eligible for inspections by persons accredited under
paragraph (2) if the following conditions are met:
``(i) The Secretary classified the results of the most
recent inspection of the establishment pursuant to subsection
(h) or (i) of section 510 as `no action indicated' or `voluntary
action indicated'.
``(ii) With respect to each inspection to be conducted by an
accredited person--
``(I) the owner or operator of the establishment
submits to the Secretary a notice requesting clearance
to use such a person to conduct the inspection, and the
Secretary provides such clearance; and
``(II) such notice identifies the accredited person
whom the establishment has selected to conduct the
inspection, and the Secretary agrees to the selected
accredited person.
``(iii) With respect to the devices that are manufactured,
prepared, propagated, compounded, or processed by the
establishment, at least one of such devices is marketed in the
United States, and the following additional conditions are met:
``(I) At least one of such devices is marketed, or
is intended to be marketed, in one or more foreign
countries, one of which countries certifies, accredits,
or otherwise recognizes the person accredited under
paragraph (2) and identified under subclause (II) of
this clause.
``(II) <<NOTE: Deadline.>> The owner or operator of
the establishment submits to the Secretary a statement
that the law of a country in which such a device is
marketed, or is intended to be marketed, recognizes an
inspection of the establishment by the Secretary, and
not later than 30 days after receiving such statement,
the Secretary informs the owner or operator of the
establishment that the owner or operator may submit a
notice requesting clearance under clause (ii).
``(iv)(I) In the case of an inspection to be conducted
pursuant to 510(h), persons accredited under paragraph (2) did
not conduct the two immediately preceding inspections of the
establishment, except that the establishment may petition the
Secretary for a waiver of such condition. Such a waiver may be
granted only if the petition states a commercial reason for the
waiver; the Secretary determines that the public health would be
served by granting the waiver; and the Secretary has conducted
an inspection of the establishment during the four-year period
preceding the date on which the notice under clause (ii) is
submitted to the Secretary. Such a waiver is deemed to be
granted only if the petition states a commercial reason for the
waiver; the Secretary has not determined that the public health
would be served by granting the waiver; and the owner or
operator of the device establishment has requested in writing,
not later than 18 months following the most recent inspection of
such establishment by a person accredited under paragraph (2),
that the Secretary inspect the establishment and the Secretary
has not conducted an inspection within 30 months after the most
recent inspection. With respect to such a waiver that is granted
or deemed to be granted, no additional such waiver may be
granted until after the Secretary has conducted an inspection of
the establishment.
[[Page 116 STAT. 1605]]
``(II) In the case of an inspection to be conducted pursuant
to 510(i), the Secretary periodically conducts inspections of
the establishment.
``(B)(i) <<NOTE: Deadline.>> The Secretary shall respond to a notice
under subparagraph (A) from a device establishment not later than 30
days after the Secretary receives the notice. Through such response, the
Secretary shall (I) provide clearance under such subparagraph, and agree
to the selection of an accredited person, or (II) make a request under
clause (ii). If the Secretary fails to respond to the notice within such
30-day period, the establishment is deemed to have such clearance, and
to have the agreement of the Secretary for such selection.
``(ii) The request referred to in clause (i)(II) is--
``(I) a request to the device establishment involved to
submit to the Secretary compliance data in accordance with
clause (iii); or
``(II) a request to the establishment, or to the accredited
person identified in the notice under subparagraph (A), for
information concerning the relationship between the
establishment and such accredited person, including information
about the number of inspections of the establishment, or other
establishments owned or operated by the owner or operator of the
establishment, that have been conducted by the accredited
person.
The Secretary may make both such requests.
``(iii) The compliance data to be submitted by a device
establishment under clause (ii) are data describing whether the quality
controls of the establishment have been sufficient for ensuring
consistent compliance with current good manufacturing practice within
the meaning of section 501(h), and data otherwise describing whether the
establishment has consistently been in compliance with sections 501 and
502 and other applicable provisions of this Act. Such data shall include
complete reports of inspections regarding good manufacturing practice or
other quality control audits that, during the preceding two-year period,
were conducted at the establishment by persons other than the owner or
operator of the establishment, together with all other compliance data
the Secretary deems necessary. Data under the preceding sentence shall
demonstrate to the Secretary whether the establishment has facilitated
consistent compliance by promptly correcting any compliance problems
identified in such inspections.
``(iv) <<NOTE: Deadline.>> Not later than 60 days after receiving
compliance data under clause (iii) from a device establishment, the
Secretary shall provide or deny clearance under subparagraph (A). The
Secretary may deny clearance if the Secretary determines that the
establishment has failed to demonstrate consistent compliance for
purposes of clause (iii). The Secretary shall provide to the
establishment a statement of such reasons for such determination. If the
Secretary fails to provide such statement to the establishment within
such 60-day period, the establishment is deemed to have such clearance.
``(v)(I) A request to an accredited person under clause (ii)(II) may
not seek any information that is not required to be maintained by such
person in records under subsection (f)(1). Not later than 60 days after
receiving the information sought by the request, the Secretary shall
agree to, or reject, the selection of such person by the device
establishment involved. The Secretary may reject
[[Page 116 STAT. 1606]]
the selection if the Secretary provides to the establishment a statement
of the reasons for such rejection. Reasons for the rejection may include
that the establishment or the accredited person, as the case may be, has
failed to fully respond to the request, or that the Secretary has
concerns regarding the relationship between the establishment and such
accredited person. If within such 60-day period the Secretary fails to
agree to or reject the selection in accordance with this subclause, the
Secretary is deemed to have agreed to the selection.
``(II) If the Secretary rejects the selection of an accredited
person by a device establishment, the establishment may make an
additional selection of an accredited person by submitting to the
Secretary a notice that identifies the additional selection. Clauses (i)
and (ii), and subclause (I) of this clause, apply to the selection of an
accredited person through a notice under the preceding sentence in the
same manner and to the same extent as such provisions apply to a
selection of an accredited person through a notice under subparagraph
(A).
``(vi) In the case of a device establishment that under clause (iv)
is denied clearance under subparagraph (A), or whose selection of an
accredited person is rejected under clause (v), the Secretary shall
designate a person to review the findings of the Secretary under such
clause if, during the 30-day period beginning on the date on which the
establishment receives the findings, the establishment requests the
review. <<NOTE: Deadline.>> The review shall commence not later than 30
days after the establishment requests the review, unless the Secretary
and the establishment otherwise agree.
``(C)(i) In the case of a device establishment for which the
Secretary classified the results of the most recent inspection of the
establishment by a person accredited under paragraph (2) as `official
action indicated', the establishment, if otherwise eligible under
subparagraph (A), is eligible for further inspections by persons
accredited under such paragraph if (I) the Secretary issues a written
statement to the owner or operator of the establishment that the
violations leading to such classification have been resolved, and (II)
the Secretary, either upon the Secretary's own initiative or a petition
of the owner or operator of the establishment, notifies the
establishment that it has clearance to use an accredited person for the
inspections. The Secretary shall respond to such petition within 30 days
after the receipt of the petition.
``(ii) If the Secretary denies a petition under clause (i), the
device establishment involved may, after the expiration of one year
after such denial, again petition the Secretary for a determination of
eligibility for inspection by persons accredited by the Secretary under
paragraph (2). If the Secretary denies such petition, the Secretary
shall provide the establishment with such reasons for such denial within
60 days after the denial. If, as of the expiration of 48 months after
the receipt of the first petition, the establishment has not been
inspected by the Secretary in accordance with section 510(h), or has not
during such period been inspected pursuant to section 510(i), as
applicable, the establishment is eligible for further inspections by
accredited persons.
``(7)(A) Persons accredited under paragraph (2) to conduct
inspections shall record in writing their inspection observations and
shall present the observations to the device establishment's designated
representative and describe each observation. Additionally, such
accredited person shall prepare an inspection report
[[Page 116 STAT. 1607]]
(including for inspections classified as `no action indicated') in a
form and manner consistent with such reports prepared by employees and
officials designated by the Secretary to conduct inspections.
``(B) At a minimum, an inspection report under subparagraph (A)
shall identify the persons responsible for good manufacturing practice
compliance at the inspected device establishment, the dates of the
inspection, the scope of the inspection, and shall describe in detail
each observation identified by the accredited person, identify other
matters that relate to or may influence compliance with this Act, and
describe any recommendations during the inspection or at the
inspection's closing meeting.
``(C) <<NOTE: Deadline.>> An inspection report under subparagraph
(A) shall be sent to the Secretary and to the designated representative
of the inspected device establishment at the same time, but under no
circumstances later than three weeks after the last day of the
inspection. The report to the Secretary shall be accompanied by all
written inspection observations previously provided to the designated
representative of the establishment.
``(D) Any statement or representation made by an employee or agent
of a device establishment to a person accredited under paragraph (2) to
conduct inspections shall be subject to section 1001 of title 18, United
States Code.
``(E) If at any time during an inspection by an accredited person
the accredited person discovers a condition that could cause or
contribute to an unreasonable risk to the public health, the accredited
person shall immediately notify the Secretary of the identification of
the device establishment subject to inspection and such condition.
``(8) Compensation for an accredited person shall be determined by
agreement between the accredited person and the person who engages the
services of the accredited person, and shall be paid by the person who
engages such services.
``(9) Nothing in this subsection affects the authority of the
Secretary to inspect any device establishment pursuant to this Act.
``(10)(A) For fiscal year 2005 and each subsequent fiscal year, no
device establishment may be inspected during the fiscal year involved by
a person accredited under paragraph (2) if--
``(i) of the amounts appropriated for salaries and expenses
of the Food and Drug Administration for the preceding fiscal
year (referred to in this subparagraph as the `first prior
fiscal year'), the amount obligated by the Secretary for
inspections of device establishments by the Secretary was less
than the adjusted base amount applicable to such first prior
fiscal year; and
``(ii) of the amounts appropriated for salaries and expenses
of the Food and Drug Administration for the fiscal year
preceding the first prior fiscal year (referred to in this
subparagraph as the `second prior fiscal year'), the amount
obligated by the Secretary for inspections of device
establishments by the Secretary was less than the adjusted base
amount applicable to such second prior fiscal year.
``(B)(i) Subject to clause (ii), the Comptroller General of the
United States shall determine the amount that was obligated by the
Secretary for fiscal year 2002 for compliance activities of the Food and
Drug Administration with respect to devices (referred
[[Page 116 STAT. 1608]]
to in this subparagraph as the `compliance budget'), and of such amount,
the amount that was obligated for inspections by the Secretary of device
establishments (referred to in this subparagraph as the `inspection
budget').
``(ii) For purposes of determinations under clause (i), the
Comptroller General shall not include in the compliance budget or the
inspection budget any amounts obligated for inspections of device
establishments conducted as part of the process of reviewing
applications under section 515.
``(iii) Not later than March 31, 2003, the Comptroller General shall
complete the determinations required in this subparagraph and submit to
the Secretary and the Congress a reporting describing the findings made
through such determinations.
``(C) For purposes of this paragraph:
``(i) The term `base amount' means the inspection budget
determined under subparagraph (B) for fiscal year 2002.
``(ii) The term `adjusted base amount', in the case of
applicability to fiscal year 2003, means an amount equal to the
base amount increased by 5 percent.
``(iii) The term `adjusted base amount', with respect to
applicability to fiscal year 2004 or any subsequent fiscal year,
means the adjusted based amount applicable to the preceding year
increased by 5 percent.
``(11) The authority provided by this subsection terminates on
October 1, 2012.
``(12) <<NOTE: Deadline. Reports.>> No later than four years after
the enactment of this subsection the Comptroller General shall report to
the Committee on Energy and Commerce of the House of Representatives and
the Committee on Health, Education, Labor and Pensions of the Senate--
``(A) the number of inspections pursuant to subsections (h)
and (i) of section 510 conducted by accredited persons and the
number of inspections pursuant to such subsections conducted by
Federal employees;
``(B) the number of persons who sought accreditation under
this subsection, as well as the number of persons who were
accredited under this subsection;
``(C) the reasons why persons who sought accreditation, but
were denied accreditation, were denied;
``(D) the number of audits conducted by the Secretary of
accredited persons, the quality of inspections conducted by
accredited persons, whether accredited persons are meeting their
obligations under this Act, and whether the number of audits
conducted is sufficient to permit these assessments;
``(E) whether this subsection is achieving the goal of
ensuring more information about device establishment compliance
is being presented to the Secretary, and whether that
information is of a quality consistent with information obtained
by the Secretary pursuant to subsection (h) or (i) of section
510;
``(F) whether this subsection is advancing efforts to allow
device establishments to rely upon third-party inspections for
purposes of compliance with the laws of foreign governments; and
``(G) whether the Congress should continue, modify, or
terminate the program under this subsection.
[[Page 116 STAT. 1609]]
``(13) The Secretary shall include in the annual report required
under section 903(g) the names of all accredited persons and the
particular activities under this subsection for which each such person
is accredited and the name of each accredited person whose accreditation
has been withdrawn during the year.
``(14) Notwithstanding any provision of this subsection, this
subsection does not have any legal effect on any agreement described in
section 803(b) between the Secretary and a foreign country.''.
(b) Maintenance of Records.--Section 704(f) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374(f)) is amended--
(1) in paragraph (1), in the first sentence, by striking ``A
person accredited'' and all that follows through ``shall
maintain records'' and inserting the following: ``An accredited
person described in paragraph (3) shall maintain records'';
(2) in paragraph (2), by striking ``a person accredited
under section 523'' and inserting ``an accredited person
described in paragraph (3)''; and
(3) by adding at the end the following paragraph:
``(3) For purposes of paragraphs (1) and (2), an accredited person
described in this paragraph is a person who--
``(A) is accredited under subsection (g); or
``(B) is accredited under section 523.''.
(c) Civil Money Penalty.--Section 303(g)(1)(A) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333(g)(1)(A)) is amended by adding at
the end the following: ``For purposes of the preceding sentence, a
person accredited under paragraph (2) of section 704(g) who is
substantially not in compliance with the standards of accreditation
under such section, or who poses a threat to public health or fails to
act in a manner that is consistent with the purposes of such section,
shall be considered to have violated a requirement of this Act that
relates to devices.''.
(d) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(gg) The knowing failure of a person accredited under paragraph
(2) of section 704(g) to comply with paragraph (7)(E) of such section;
the knowing inclusion by such a person of false information in an
inspection report under paragraph (7)(A) of such section; or the knowing
failure of such a person to include material facts in such a report.''.
(e) Conforming Amendment.--Section 510(h) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(h)) is amended by inserting after ``duly
designated by the Secretary'' the following: ``, or by persons
accredited to conduct inspections under section 704(g),''.
SEC. 202. THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.
Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360m) is amended--
(1) in subsection (c), by striking ``The authority'' and all
that follows and inserting the following: ``The authority
provided by this section terminates October 1, 2007.''; and
(2) by adding at the end the following subsection:
``(d) Report.--Not <<NOTE: Deadline.>> later than January 10, 2007,
the Secretary shall conduct a study based on the experience under the
program under this section and submit to the Committee on Energy and
[[Page 116 STAT. 1610]]
Commerce of the House of Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate, a report describing the
findings of the study. The objectives of the study shall include
determining--
``(1) the number of devices reviewed under this section;
``(2) the number of devices reviewed under this section that
were ultimately cleared by the Secretary;
``(3) the number of devices reviewed under this section that
were ultimately not cleared by the Secretary;
``(4) the average time period for a review under this
section (including the time it takes for the Secretary to review
a recommendation of an accredited person under subsection (a)
and determine the initial device classification);
``(5) the average time period identified in paragraph (4)
compared to the average time period for review of devices solely
by the Secretary pursuant to section 510(k);
``(6) if there is a difference in the average time period
under paragraph (4) and the average time period under paragraph
(5), the reasons for such difference;
``(7) whether the quality of reviews under this section for
devices for which no guidance has been issued is qualitatively
inferior to reviews by the Secretary for devices for which no
guidance has been issued;
``(8) whether the quality of reviews under this section of
devices for which no guidance has been issued is qualitatively
inferior to reviews under this section of devices for which
guidance has been issued;
``(9) whether this section has in any way jeopardized or
improved the public health;
``(10) any impact of this section on resources available to
the Secretary to review reports under section 510(k); and
``(11) any suggestions for continuation, modification
(including contraction or expansion of device eligibility), or
termination of this section that the Secretary determines to be
appropriate.''.
SEC. 203. DEBARMENT OF ACCREDITED PERSONS.
Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
335a) is amended by adding at the end the following subsection:
``(m) Devices; Mandatory Debarment Regarding Third-Party Inspections
and Reviews.--
``(1) In general.--If the Secretary finds that a person has
been convicted of a felony under section 301(gg), the Secretary
shall debar such person from being accredited under section
523(b) or 704(g)(2) and from carrying out activities under an
agreement described in section 803(b).
``(2) Debarment period.--The Secretary shall debar a person
under paragraph (1) for the following periods:
``(A) The period of debarment of a person (other
than an individual) shall not be less than 1 year or
more than 10 years, but if an act leading to a
subsequent debarment under such paragraph occurs within
10 years after such person has been debarred under such
paragraph, the period of debarment shall be permanent.
``(B) The debarment of an individual shall be
permanent.
[[Page 116 STAT. 1611]]
``(3) Termination of debarment; judicial review; other
matters.--Subsections (c)(3), (d), (e), (i), (j), and (l)(1)
apply with respect to a person (other than an individual) or an
individual who is debarred under paragraph (1) to the same
extent and in the same manner as such subsections apply with
respect to a person who is debarred under subsection (a)(1), or
an individual who is debarred under subsection (a)(2),
respectively.''.
SEC. 204. DESIGNATION AND REGULATION OF COMBINATION PRODUCTS.
Section 503(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353(g)) is amended--
(1) in paragraph (1)--
(A) in the first sentence, by striking ``shall
designate a component of the Food and Drug
Administration'' and inserting ``shall in accordance
with this subsection assign an agency center''; and
(B) in each of subparagraphs (A) through (C), by
striking ``the persons charged'' and inserting ``the
agency center charged'';
(2) by redesignating paragraph (4) as paragraph (5);
(3) by inserting after paragraph (3) the following
paragraph:
``(4)(A) <<NOTE: Deadline.>> Not later than 60 days after the date
of the enactment of this paragraph, the Secretary shall establish within
the Office of the Commissioner of Food and Drugs an office to ensure the
prompt assignment of combination products to agency centers, the timely
and effective premarket review of such products, and consistent and
appropriate postmarket regulation of like products subject to the same
statutory requirements to the extent permitted by law. Additionally, the
office shall, in determining whether a product is to be designated a
combination product, consult with the component within the Office of the
Commissioner of Food and Drugs that is responsible for such
determinations. Such office (referred to in this paragraph as the
`Office') shall have appropriate scientific and medical expertise, and
shall be headed by a director.
``(B) In carrying out this subsection, the Office shall, for each
combination product, promptly assign an agency center with primary
jurisdiction in accordance with paragraph (1) for the premarket review
of such product.
``(C)(i) In carrying out this subsection, the Office shall ensure
timely and effective premarket reviews by overseeing the timeliness of
and coordinating reviews involving more than one agency center.
``(ii) In order to ensure the timeliness of the premarket review of
a combination product, the agency center with primary jurisdiction for
the product, and the consulting agency center, shall be responsible to
the Office with respect to the timeliness of the premarket review.
``(D) In carrying out this subsection, the Office shall ensure the
consistency and appropriateness of postmarket regulation of like
products subject to the same statutory requirements to the extent
permitted by law.
``(E)(i) Any dispute regarding the timeliness of the premarket
review of a combination product may be presented to the Office for
resolution, unless the dispute is clearly premature.
[[Page 116 STAT. 1612]]
``(ii) During the review process, any dispute regarding the
substance of the premarket review may be presented to the Commissioner
of Food and Drugs after first being considered by the agency center with
primary jurisdiction of the premarket review, under the scientific
dispute resolution procedures for such center. The Commissioner of Food
and Drugs shall consult with the Director of the Office in resolving the
substantive dispute.
``(F) The Secretary, acting through the Office, shall review each
agreement, guidance, or practice of the Secretary that is specific to
the assignment of combination products to agency centers and shall
determine whether the agreement, guidance, or practice is consistent
with the requirements of this subsection. In carrying out such review,
the Secretary shall consult with stakeholders and the directors of the
agency centers. <<NOTE: Federal Register, publication. Notice.>> After
such consultation, the Secretary shall determine whether to continue in
effect, modify, revise, or eliminate such agreement, guidance, or
practice, and shall publish in the Federal Register a notice of the
availability of such modified or revised agreement, guidance or
practice. Nothing in this paragraph shall be construed as preventing the
Secretary from following each agreement, guidance, or practice until
continued, modified, revised, or eliminated.
``(G) <<NOTE: Deadline. Reports.>> Not later than one year after the
date of the enactment of this paragraph and annually thereafter, the
Secretary shall report to the appropriate committees of Congress on the
activities and impact of the Office. The report shall include
provisions--
``(i) describing the numbers and types of combination
products under review and the timeliness in days of such
assignments, reviews, and dispute resolutions;
``(ii) identifying the number of premarket reviews of such
products that involved a consulting agency center; and
``(iii) describing improvements in the consistency of
postmarket regulation of combination products.
``(H) Nothing in this paragraph shall be construed to limit the
regulatory authority of any agency center.''; and
(4) in paragraph (5) (as redesignated by paragraph (2) of
this section)--
(A) by redesignating subparagraphs (A) and (B) as
subparagraphs (B) and (C), respectively; and
(B) by inserting before subparagraph (B) the
following subparagraph:
``(A) The term `agency center' means a center or alternative
organizational component of the Food and Drug Administration.''.
SEC. 205. <<NOTE: 21 USC 360e note.>> REPORT ON CERTAIN DEVICES.
Not <<NOTE: Deadline.>> later than one year after the date of
enactment of this Act, the Secretary of Health and Human Services shall
report to the appropriate committees of Congress on the timeliness and
effectiveness of device premarket reviews by centers other than the
Center for Devices and Radiological Health. Such report shall include
information on the times required to log in and review original
submissions and supplements, times required to review manufacturers'
replies to submissions, and times to approve or clear such devices. Such
report shall contain the Secretary's recommendations on any measures
needed to improve performance including, but not limited to, the
allocation of additional resources.
[[Page 116 STAT. 1613]]
Such report also shall include the Secretary's specific recommendation
on whether responsibility for regulating such devices should be
reassigned to those persons within the Food and Drug Administration who
are primarily charged with regulating other types of devices, and
whether such a transfer could have a deleterious impact on the public
health and on the safety of such devices.
SEC. 206. ELECTRONIC LABELING.
Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(f)) is amended by adding at the end the following: ``Required
labeling for prescription devices intended for use in health care
facilities may be made available solely by electronic means provided
that the labeling complies with all applicable requirements of law and,
that the manufacturer affords health care facilities the opportunity to
request the labeling in paper form, and after such request, promptly
provides the health care facility the requested information without
additional cost.''.
SEC. 207. ELECTRONIC REGISTRATION.
Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360) is amended by adding at the end the following:
``(p) Registrations under subsections (b), (c), (d), and (i)
(including the submission of updated information) shall be submitted to
the Secretary by electronic means, upon a finding by the Secretary that
the electronic receipt of such registrations is feasible, unless the
Secretary grants a request for waiver of such requirement because use of
electronic means is not reasonable for the person requesting such
waiver.''.
SEC. 208. INTENDED USE.
Section 513(i)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360c(i)(1)(E)) is amended by striking clause (iv).
SEC. 209. MODULAR REVIEW.
Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e(c)) is amended by adding at the end the following:
``(3)(A) Prior to the submission of an application under this
subsection, the Secretary shall accept and review any portion of the
application that the applicant and the Secretary agree is complete,
ready, and appropriate for review, except that such requirement does not
apply, and the Secretary has discretion whether to accept and review
such portion, during any period in which, under section 738(g), the
Secretary does not have the authority to collect fees under section
738(a).
``(B) Each portion of a submission reviewed under subparagraph (A)
and found acceptable by the Secretary shall not be further reviewed
after receipt of an application that satisfies the requirements of
paragraph (1), unless an issue of safety or effectiveness provides the
Secretary reason to review such accepted portion.
``(C) Whenever the Secretary determines that a portion of a
submission under subparagraph (A) is unacceptable, the Secretary shall,
in writing, provide to the applicant a description of any deficiencies
in such portion and identify the information that is required to correct
these deficiencies, unless the applicant is no longer pursuing the
application.''.
[[Page 116 STAT. 1614]]
SEC. 210. PEDIATRIC EXPERTISE REGARDING CLASSIFICATION-PANEL REVIEW OF
PREMARKET APPLICATIONS.
Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e(c)), as amended by section 302(c)(2)(A) of this Act, is
amended in paragraph (3) by adding at the end the following: ``Where
appropriate, the Secretary shall ensure that such panel includes, or
consults with, one or more pediatric experts.''.
SEC. 211. INTERNET LIST OF CLASS II DEVICES EXEMPTED FROM REQUIREMENT OF
PREMARKET NOTIFICATION.
Section 510(m)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(m)(1)) is amended by adding at the end the following: ``The
Secretary shall publish such list on the Internet site of the Food and
Drug Administration. The list so published shall be updated not later
than 30 days after each revision of the list by the Secretary.''.
SEC. 212. <<NOTE: 21 USC 360l note.>> STUDY BY INSTITUTE OF MEDICINE OF
POSTMARKET SURVEILLANCE REGARDING PEDIATRIC POPULATIONS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall request the
Institute of Medicine to enter into an agreement with the Secretary
under which such Institute conducts a study for the purpose of
determining whether the system under the Federal Food, Drug, and
Cosmetic Act for the postmarket surveillance of medical devices provides
adequate safeguards regarding the use of devices in pediatric
populations.
(b) Certain Matters.--The Secretary shall ensure that determinations
made in the study under subsection (a) include determinations of--
(1) whether postmarket surveillance studies of implanted
medical devices are of long enough duration to evaluate the
impact of growth and development for the number of years that
the child will have the implant, and whether the studies are
adequate to evaluate how children's active lifestyles may affect
the failure rate and longevity of the implant; and
(2) whether the postmarket surveillance by the Food and Drug
Administration of medical devices used in pediatric populations
is sufficient to provide adequate safeguards for such
populations, taking into account the Secretary's monitoring of
commitments made at the time of approval of medical devices,
such as phase IV trials, and the Secretary's monitoring and use
of adverse reaction reports, registries, and other postmarket
surveillance activities.
(c) Report to Congress.--The <<NOTE: Deadline.>> Secretary shall
ensure that, not later than four years after the date of the enactment
of this Act, a report describing the findings of the study under
subsection (a) is submitted to the Congress. The report shall include
any recommendations of the Secretary for administrative or legislative
changes to the system of postmarket surveillance referred to in such
subsection.
SEC. 213. <<NOTE: 21 USC 360j note.>> GUIDANCE REGARDING PEDIATRIC
DEVICES.
Not <<NOTE: Deadline.>> later than 270 days after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
issue guidance on the following:
[[Page 116 STAT. 1615]]
(1) The type of information necessary to provide reasonable
assurance of the safety and effectiveness of medical devices
intended for use in pediatric populations.
(2) Protections for pediatric subjects in clinical
investigations of the safety or effectiveness of such devices.
SEC. 214. <<NOTE: 42 USC 289g-3 note.>> BREAST IMPLANTS; STUDY BY
COMPTROLLER GENERAL.
(a) In General.--The Comptroller General of the United States shall
conduct a study to determine the following with respect to breast
implants:
(1) The content of information typically provided by health
professionals to women who consult with such professionals on
the issue of whether to undergo breast implant surgery.
(2) Whether such information is provided by physicians or
other health professionals, and whether the information is
provided verbally or in writing, and at what point in the
process of determining whether to undergo surgery is such
information provided.
(3) Whether the information presented, as a whole, provides
a complete and accurate discussion of the risks and benefits of
breast implants, and the extent to which women who receive such
information understand the risks and benefits.
(4) The number of adverse events that have been reported,
and whether such events have been adequately investigated.
(5) With respect to women who participate as subjects in
research being carried out regarding the safety and
effectiveness of breast implants:
(A) The content of information provided to the women
during the process of obtaining the informed consent of
the women to be subjects, and the extent to which such
information is updated.
(B) Whether such process provides written
explanations of the criteria for being subjects in the
research.
(C) The point at which, in the planning or conduct
of the research, the women are provided information
regarding the provision of informed consent to be
subjects.
(b) Report.--The Comptroller General shall submit to the Congress a
report describing the findings of the study.
(c) Definition.--For purposes of this section, the term ``breast
implant'' means a breast prosthesis that is implanted to augment or
reconstruct the female breast.
SEC. 215. BREAST IMPLANTS; RESEARCH THROUGH NATIONAL INSTITUTES OF
HEALTH.
(a) Report on Status of Current Research.--
Not <<NOTE: Deadline. Reports.>> later than 180 days after the date of
the enactment of this Act, the Director of the National Institutes of
Health shall submit to the Congress a report describing the status of
research on breast implants (as defined in section 213(c)) being
conducted or supported by such Institutes.
(b) Research on Long-Term Implications.--Part H of title IV of the
Public Health Service Act (42 U.S.C. 289 et seq.) is amended by adding
at the end of the following section:
``SEC. 498C. <<NOTE: 42 USC 289g-3.>> BREAST IMPLANT RESEARCH.
``(a) In General.--The Director of NIH may conduct or support
research to examine the long-term health implications of silicone
[[Page 116 STAT. 1616]]
breast implants, both gel and saline filled. Such research studies may
include the following:
``(1) Developing and examining techniques to measure
concentrations of silicone in body fluids and tissues.
``(2) Surveillance of recipients of silicone breast
implants, including long-term outcomes and local complications.
``(b) Definition.--For purposes of this section, the term `breast
implant' means a breast prosthesis that is implanted to augment or
reconstruct the female breast.''.
TITLE III--ADDITIONAL AMENDMENTS
SEC. 301. IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES.
(a) In General.--Section 502 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 352) is amended by adding at the end the following:
``(u) If it is a device, unless it, or an attachment thereto,
prominently and conspicuously bears the name of the manufacturer of the
device, a generally recognized abbreviation of such name, or a unique
and generally recognized symbol identifying such manufacturer, except
that the Secretary may waive any requirement under this paragraph for
the device if the Secretary determines that compliance with the
requirement is not feasible for the device or would compromise the
provision of reasonable assurance of the safety or effectiveness of the
device.''.
(b) Effective Date.--The <<NOTE: 21 USC 352 note.>> amendment made
by subsection (a) takes effect 18 months after the date of the enactment
of this Act, and only applies to devices introduced or delivered for
introduction into interstate commerce after such effective date.
SEC. 302. SINGLE-USE MEDICAL DEVICES.
(a) Required Statements on Labeling.--
(1) In general.--Section 502 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 301 of this Act, is amended
by adding at the end the following:
``(v) If it is a reprocessed single-use device, unless all labeling
of the device prominently and conspicuously bears the statement
`Reprocessed device for single use. Reprocessed by ____.' The name of
the manufacturer of the reprocessed device shall be placed in the space
identifying the person responsible for reprocessing.''.
(2) Effective date.--The amendment made by paragraph (1)
takes effect 15 months after the date of the enactment of this
Act, and only applies to devices introduced or delivered for
introduction into interstate commerce after such effective date.
(b) Premarket Notification.--Section <<NOTE: 21 USC 352 note.>> 510
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended
by inserting after subsection (n) the following:
``(o)(1) With respect to reprocessed single-use devices for which
reports are required under subsection (k):
``(A) The Secretary shall identify such devices or types of
devices for which reports under such subsection must, in order
to ensure that the device is substantially equivalent to a
predicate device, include validation data, the types of which
shall be specified by the Secretary, regarding cleaning and
sterilization, and functional performance demonstrating
[[Page 116 STAT. 1617]]
that the single-use device will remain substantially equivalent
to its predicate device after the maximum number of times the
device is reprocessed as intended by the person submitting the
premarket notification. <<NOTE: Federal Register,
publication.>> Within six months after enactment of this
subsection, the Secretary shall publish in the Federal Register
a list of the types so identified, and shall revise the list as
appropriate. Reports under subsection (k) for devices or types
of devices within a type included on the list are, upon
publication of the list, required to include such validation
data.
``(B) <<NOTE: Deadline.>> In the case of each report under
subsection (k) that was submitted to the Secretary before the
publication of the initial list under subparagraph (A), or any
revision thereof, and was for a device or type of device
included on such list, the person who submitted the report under
subsection (k) shall submit validation data as described in
subparagraph (A) to the Secretary not later than nine months
after the publication of the list. During such nine-month
period, the Secretary may not take any action under this Act
against such device solely on the basis that the validation data
for the device have not been submitted to the Secretary. After
the submission of the validation data to the Secretary, the
Secretary may not determine that the device is misbranded under
section 502(o), adulterated under section 501(f)(1)(B), or take
action against the device under section 301(p) for failure to
provide any information required by subsection (k) until (i) the
review is terminated by withdrawal of the submission of the
report under subsection (k); (ii) the Secretary finds the data
to be acceptable and issues a letter; or (iii) the Secretary
determines that the device is not substantially equivalent to a
predicate device. Upon a determination that a device is not
substantially equivalent to a predicate device, or if such
submission is withdrawn, the device can no longer be legally
marketed.
``(C) In the case of a report under subsection (k) for a
device identified under subparagraph (A) that is of a type for
which the Secretary has not previously received a report under
such subsection, the Secretary may, in advance of revising the
list under subparagraph (A) to include such type, require that
the report include the validation data specified in subparagraph
(A).
``(D) Section 502(o) applies with respect to the failure of
a report under subsection (k) to include validation data
required under subparagraph (A).
``(2) With respect to critical or semi-critical reprocessed single-
use devices that, under subsection (l) or (m), are exempt from the
requirement of submitting reports under subsection (k):
``(A) The Secretary shall identify such devices or types of
devices for which such exemptions should be terminated in order
to provide a reasonable assurance of the safety and
effectiveness of the devices. <<NOTE: Federal Register,
publication.>> The Secretary shall publish in the Federal
Register a list of the devices or types of devices so
identified, and shall revise the list as appropriate. The
exemption for each device or type included on the list is
terminated upon the publication of the list. For each report
under subsection (k) submitted pursuant to this subparagraph the
Secretary shall require the validation data described in
paragraph (1)(A).
[[Page 116 STAT. 1618]]
``(B) For each device or type of device included on the list
under subparagraph (A), a report under subsection (k) shall be
submitted to the Secretary not later than 15 months after the
publication of the initial list, or a revision of the list,
whichever terminates the exemption for the device. During such
15-month period, the Secretary may not take any action under
this Act against such device solely on the basis that such
report has not been submitted to the Secretary. After the
submission of the report to the Secretary the Secretary may not
determine that the device is misbranded under section 502(o),
adulterated under section 501(f)(1)(B), or take action against
the device under section 301(p) for failure to provide any
information required by subsection (k) until (i) the review is
terminated by withdrawal of the submission; (ii) the Secretary
determines by order that the device is substantially equivalent
to a predicate device; or (iii) the Secretary determines by
order that the device is not substantially equivalent to a
predicate device. Upon a determination that a device is not
substantially equivalent to a predicate device, the device can
no longer be legally marketed.
``(C) <<NOTE: Deadlines.>> In the case of semi-critical
devices, the initial list under subparagraph (A) shall be
published not later than 18 months after the effective date of
this subsection. In the case of critical devices, the initial
list under such subparagraph shall be published not later than
six months after such effective date.
``(D) Section 502(o) applies with respect to the failure to
submit a report under subsection (k) that is required pursuant
to subparagraph (A), including a failure of the report to
include validation data required in such subparagraph.
``(E) The termination under subparagraph (A) of an exemption
under subsection (l) or (m) for a critical or semicritical
reprocessed single-use device does not terminate the exemption
under subsection (l) or (m) for the original device.''.
(c) Premarket Report.--Section 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e) is amended--
(1) in subsection (a), in the matter after and below
paragraph (2), by inserting before the period the following:
``or, as applicable, an approval under subsection (c)(2) of a
report seeking premarket approval''; and
(2) in subsection (c)--
(A) by redesignating paragraph (2) as paragraph (3);
and
(B) by inserting after paragraph (1) the following
paragraph:
``(2)(A) Any person may file with the Secretary a report seeking
premarket approval for a class III device referred to in subsection (a)
that is a reprocessed single-use device. Such a report shall contain the
following:
``(i) The device name, including both the trade or
proprietary name and the common or usual name.
``(ii) The establishment registration number of the owner or
operator submitting the report.
``(iii) Actions taken to comply with performance standards
under section 514.
[[Page 116 STAT. 1619]]
``(iv) Proposed labels, labeling, and advertising sufficient
to describe the device, its intended use, and directions for
use.
``(v) Full reports of all information, published or known to
or which should be reasonably known to the applicant, concerning
investigations which have been made to show whether or not the
device is safe or effective.
``(vi) A description of the device's components,
ingredients, and properties.
``(vii) A full description of the methods used in, and the
facilities and controls used for, the reprocessing and packing
of the device.
``(viii) Such samples of the device that the Secretary may
reasonably require.
``(ix) A financial certification or disclosure statement or
both, as required by part 54 of title 21, Code of Federal
Regulations.
``(x) A statement that the applicant believes to the best of
the applicant's knowledge that all data and information
submitted to the Secretary are truthful and accurate and that no
material fact has been omitted in the report.
``(xi) Any additional data and information, including
information of the type required in paragraph (1) for an
application under such paragraph, that the Secretary determines
is necessary to determine whether there is reasonable assurance
of safety and effectiveness for the reprocessed device.
``(xii) Validation data described in section 510(o)(1)(A)
that demonstrates that the reasonable assurance of the safety or
effectiveness of the device will remain after the maximum number
of times the device is reprocessed as intended by the person
submitting such report.
``(B) In the case of a class III device referred to in subsection
(a) that is a reprocessed single-use device:
``(i) Subparagraph (A) of this paragraph applies in lieu of
paragraph (1).
``(ii) Subject to clause (i), the provisions of this section
apply to a report under subparagraph (A) to the same extent and
in the same manner as such provisions apply to an application
under paragraph (1).
``(iii) Each reference in other sections of this Act to an
application under this section, other than such a reference in
section 737 or 738, shall be considered to be a reference to a
report under subparagraph (A).
``(iv) Each reference in other sections of this Act to a
device for which an application under this section has been
approved, or has been denied, suspended, or withdrawn, other
than such a reference in section 737 or 738, shall be considered
to be a reference to a device for which a report under
subparagraph (A) has been approved, or has been denied,
suspended, or withdrawn, respectively.''.
(d) Definitions.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the
following:
``(ll)(1) The term `single-use device' means a device that is
intended for one use, or on a single patient during a single procedure.
[[Page 116 STAT. 1620]]
``(2)(A) The term `reprocessed', with respect to a single-use
device, means an original device that has previously been used on a
patient and has been subjected to additional processing and
manufacturing for the purpose of an additional single use on a patient.
The subsequent processing and manufacture of a reprocessed single-use
device shall result in a device that is reprocessed within the meaning
of this definition.
``(B) A single-use device that meets the definition under clause (A)
shall be considered a reprocessed device without regard to any
description of the device used by the manufacturer of the device or
other persons, including a description that uses the term `recycled'
rather than the term `reprocessed'.
``(3) The term `original device' means a new, unused single-use
device.
``(mm)(1) The term `critical reprocessed single-use device' means a
reprocessed single-use device that is intended to contact normally
sterile tissue or body spaces during use.
``(2) The term `semi-critical reprocessed single-use device' means a
reprocessed single-use device that is intended to contact intact mucous
membranes and not penetrate normally sterile areas of the body.''.
SEC. 303. MEDWATCH.
Not later <<NOTE: Deadline.>> than 6 months after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
modify the MedWatch mandatory and voluntary forms to facilitate the
reporting of information by user facilities or distributors as
appropriate relating to reprocessed single-use devices, including the
name of the reprocessor and whether the device has been reused.
Approved October 26, 2002.
LEGISLATIVE HISTORY--H.R. 5651:
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CONGRESSIONAL RECORD, Vol. 148 (2002):
Oct. 16, considered and passed House.
Oct. 17, considered and passed Senate.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002):
Oct. 26, 28, Presidential remarks and statement.
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