
[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Unique Device Identification: Direct Marking of Devices; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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availability of the draft guidance entitled ``Unique Device 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 24, 2015.

ADDRESSES: An electronic copy of the draft guidance document is 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INFORMATION section for information on electronic access to the draft 
guidance. Submit written requests for a single hard copy of the draft 
guidance document entitled ``Unique Device Identification: Direct 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: GUDIDSupport@fda.hhs.gov.

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 CDRH-Guidance@fda.hhs.gov 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]
 BILLING CODE 4164-01-P


