[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Notices]
[Pages 547-549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29158]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-4048]
Safer Technologies Program for Medical Devices; Guidance for
Industry and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Safer Technologies
Program for Medical Devices.'' This final guidance describes a new,
voluntary program for certain medical devices and device-led
combination products that are reasonably expected to significantly
improve the safety of currently available treatments or diagnostics
that target an underlying disease or condition associated with
morbidities and mortalities less serious than those eligible for the
Breakthrough Devices Program. Devices and device-led combination
products are eligible for this program if they are subject to review
under a premarket approval application (PMA), De Novo classification
request (``De Novo request''), or premarket notification (510(k)),
taking into account the specific eligibility factors described in this
guidance. Consistent with the Agency's statutory mission to protect and
promote public health, FDA believes that this ``Safer Technologies
Program'' or ``STeP'' will help patients have more timely access to
these medical devices and device-led combination products by expediting
their development, assessment, and review, while preserving the
statutory standards for premarket approval, De Novo marketing
authorization, and 510(k) clearance.
DATES: The announcement of the guidance is published in the Federal
Register on January 6, 2021.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-D-4048 for ``Safer Technologies Program for Medical Devices.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Safer Technologies Program for Medical Devices'' to the Office of
Policy, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Christina Savisaar, Center for Devices
[[Page 548]]
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G221, Silver Spring, MD 20993-0002, 301-
796-6404 or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is introducing a new, voluntary program for certain medical
devices and device-led combination products that are reasonably
expected to significantly improve the safety of currently available
treatments or diagnostics that target an underlying disease or
condition associated with morbidities and mortalities less serious than
those eligible for the Breakthrough Devices Program; for example, this
may include devices treating or diagnosing non-life-threatening or
reasonably reversible conditions. Devices and device-led combination
products are eligible for this program if they are subject to review
under a premarket approval application (PMA), De Novo classification
request (``De Novo request''), or premarket notification (510(k)),
taking into account the specific eligibility factors described in this
guidance. Consistent with the Agency's statutory mission to protect and
promote public health, FDA believes that this ``Safer Technologies
Program'' or ``STeP'' will help patients have more timely access to
these medical devices and device-led combination products by expediting
their development, assessment, and review, while preserving the
statutory standards for premarket approval, De Novo marketing
authorization, and 510(k) clearance. FDA has modeled STeP on the key
principles and features of FDA's Breakthrough Devices Program as
mandated in section 515B of the Federal Food, Drug and Cosmetic Act (21
U.S.C. 360e-3) and further described in the FDA guidance document
entitled ``Breakthrough Devices Program'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program). As resources permit, FDA intends for STeP to
incorporate similar features offered under the Breakthrough Devices
Program, such as interactive and timely communications, early
engagement on Data Development Plans, sprint discussions, and senior
management engagement.
FDA recognizes and anticipates that the Agency may need up to 60
days to perform activities to operationalize STeP following issuance of
the final guidance. FDA does not intend to accept requests for
inclusion in STeP within this time period.
A notice of availability of the draft guidance appeared in the
Federal Register of September 19, 2019 (84 FR 49306). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including revisions related to program scope, such as
providing additional examples of devices that may be eligible for the
program, and revisions to clarify the review time clock. The guidance
was also revised to further emphasize that participation in STeP does
not change or impact the statutory requirements for marketing
authorization applicable to a medical device nor does it affect the
application of least burdensome policies and approaches.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Safer Technologies Program for Medical
Devices. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
II. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic
copy of ``Safer Technologies Program for Medical Devices'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 19001 and complete
title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations and guidance have been
approved by OMB as listed in the following table:
------------------------------------------------------------------------
OMB Control
21 CFR part or guidance Topic No.
------------------------------------------------------------------------
807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
812............................ Investigational Device 0910-0078
Exemption.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
``De Novo Classification De Novo classification 0910-0844
Process (Evaluation of process.
Automatic Class III
Designation)''.
``Requests for Feedback and Q-submissions.......... 0910-0756
Meetings for Medical Device
Submissions: The Q-Submission
Program''.
------------------------------------------------------------------------
[[Page 549]]
Dated: December 29, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29158 Filed 1-5-21; 8:45 am]
BILLING CODE 4164-01-P