82 FR 54387 - Unique Device Identification: Direct Marking of Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 221 (November 17, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Unique Device Identification: Direct Marking of Devices.'' This document is intended to clarify when direct marking of devices with a unique device identifier (UDI) is required, and to assist industry and FDA staff in understanding direct marking requirements.

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54387-54388]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24992]


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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; Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Unique Device 
Identification: Direct Marking of Devices.'' This document is intended 
to clarify when direct marking of devices with a unique device 
identifier (UDI) is required, and to assist industry and FDA staff in 
understanding direct marking requirements.

DATES: The announcement of the guidance is published in the Federal 
Register on November 17, 2017.

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-2015-D-2245 for ``Unique Device Identification: Direct Marking of 
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.
     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.thefederalregister.org/fdsys/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.
    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 
``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, 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 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002, 301-
496-6404, email: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 54388]]

I. Background

    Section 801.45 (21 CFR 801.45) requires a device to be directly 
marked with a UDI when the device is intended to be used more than once 
and intended to be reprocessed before each use. However, ``intended to 
be used more than once'' and ``intended to be reprocessed'' are not 
defined in the UDI regulations. This guidance provides FDA's 
interpretation of these terms, clarifies when direct marking of devices 
with a UDI is required, provides recommendations for how labelers 
should comply with the UDI direct marking requirements, and clarifies 
the criteria for exceptions to the direct marking requirement.
    In the Federal Register of June 26, 2015, FDA published the notice 
of availability of ``Draft Guidance for Industry and Food and Drug 
Administration Staff: Unique Device Identification: Direct Marking of 
Devices'' (80 FR 36821) (the ``Draft Guidance''). In the notice of 
availability, FDA also solicited feedback on two questions related to 
interpretation of ``intended to be reprocessed'': (1) Should the 
definition of ``reprocessing'' for purposes of UDI direct marking 
requirements include cleaning alone without subsequent disinfection 
and/or sterilization of the device? and (2) 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? 
Interested persons were invited to comment by September 24, 2015. FDA 
considered the comments received on the draft guidance, including 
comments responding to the specific questions in the notice of 
availability, and revised the guidance as appropriate in response to 
these comments.

II. Significance of Guidance

    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 ``Unique Device Identification: Direct 
Marking of 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. This guidance is not subject to Executive Order 12866.

III. 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://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 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; the collections of information in 21 CFR part 820 have been 
approved under OMB control number 0910-0073; 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.

    Dated: November 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-24992 Filed 11-16-17; 8:45 am]
 BILLING CODE 4164-01-P