[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36821-36822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15719]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-2245]
Unique Device Identification: Direct Marking of Devices; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability and Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Unique Device
Identification: Direct Marking of Devices.'' Direct marking is an
important feature of FDA's unique device identification system. This
document is intended to assist industry and FDA staff to understand
FDA's requirements for direct marking of devices with a unique device
identifier (UDI). In addition, FDA is seeking information on what
processes should be considered to meet the definition of
``reprocessing'' for purposes of UDI direct marking requirements.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 24, 2015.
ADDRESSES: An electronic copy of the draft guidance document is
available for download from the Internet. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the draft
guidance. Submit written requests for a single hard copy of the draft
guidance document entitled ``Unique Device Identification: Direct
Marking of Devices'' to the Office of the Center Director, 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. Send one self-addressed adhesive label to
assist that office in processing your request.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: UDI Regulatory Policy Support, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-
0002, 301-796-5995, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 226 of the Food and Drug Administration Amendments Act of
2007 and section 614 of the Food and Drug Administration Safety and
Innovation Act amended the Federal Food, Drug, and Cosmetic Act to add
section 519(f) (21 U.S.C. 360i(f)), which directs FDA to issue
regulations establishing a unique device identification system for
medical devices along with implementation timeframes for certain
medical devices. The unique device identification system final rule was
published on September 24, 2013 (78 FR 58786) (the UDI Rule).
21 CFR 801.45 requires a device bear a permanent UDI marking if the
device is intended to be used more than once and intended to be
reprocessed before each use. It details the UDI format when provided as
a direct marking, and provides criteria for exceptions to this UDI
direct marking requirement. As explained in the preamble of the UDI
Rule, UDI direct marking requirements apply to devices that are
intended to be used for months or years, sometimes many years. Because
such devices are intended to be reprocessed and reused, they will
inevitably be separated from their original labels and device packages.
UDI direct marking helps to ensure the adequate identification of such
devices through their distribution and use. However, the UDI Rule does
not define ``intended to be used more than once'' and ``reprocessed.''
FDA's interpretation of these terms is included in this draft guidance,
but FDA seeks additional information on its current definition of
``reprocessing'' for purposes of UDI direct marking requirements.
FDA guidance entitled ``Reprocessing Medical Devices in Health Care
Settings: Validation Methods and Labeling; Guidance for Industry and
Food and Drug Administration Staff'' issued on March 17, 2015
(available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf) (the
Reprocessing Guidance), indicates that reprocessing of reusable devices
[[Page 36822]]
generally encompasses three steps--point-of-use processing, thorough
cleaning, and disinfection or sterilization. The Reprocessing Guidance
makes clear, however, that certain devices may be suitably reprocessed
after cleaning alone and may not require further disinfection or
sterilization. It is important to note that the Reprocessing Guidance
is intended, among other things, to provide guidance in crafting and
validating reprocessing instructions to be included in the labeling of
reusable devices generally, and it may not be applicable for
determining whether a UDI direct marking should be required on a
specific device intended to be reused. For purposes of UDI direct
marking requirements, FDA considers a device that is intended to be
cleaned and either sterilized or disinfected to be intended to be
reprocessed. FDA has some concern about whether cleaning alone, without
subsequent sterilization and/or disinfection, should fit within the
definition of ``reprocessing'' for purposes of UDI direct marking
requirements. Therefore, FDA is seeking additional information on this
issue. FDA is particularly interested in receiving information relating
to the following questions:
FDA is concerned that devices intended to be used more
than once tend to be separated from its original label during
reprocessing, making accurate identification of devices difficult or
impossible. Should the definition of ``reprocessing'' for purposes of
UDI direct marking requirements include cleaning alone without
subsequent disinfection and/or sterilization of the device?
What public health benefits would be served by requiring a
UDI direct marking to be affixed to devices intended to be reused for
which reprocessing instructions include cleaning only and not
disinfection and/or sterilization?
This draft guidance, when finalized, is intended to assist
industry, particularly labelers, as defined under 21 CFR 801.3, and FDA
staff understand FDA's requirements for UDI direct marking of devices,
and the criteria for exceptions.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance
represents the Agency's current thinking on ``Unique Device
Identification: Direct Marking of Devices.'' It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Unique Device
Identification: Direct Marking of Devices'' may send an email request
to [email protected] to receive an electronic copy of the
document. Please use the document number 1400031 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information described in FDA regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 801 have been
approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
814, subparts A through E, have been approved under OMB control number
0910-0231; and the collections of information in 21 CFR part 830
pertaining to GUDID labeler accounts and data submissions addressed in
this draft guidance document have been approved under OMB control
number 0910-0720.
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15719 Filed 6-25-15; 8:45 am]
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