Document ID: FDA-2014-N-1048-0014
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Requirements; Unique Device Identification
Posted Date: 2023-02-14T05:00Z

[Federal Register Volume 88, Number 30 (Tuesday, February 14, 2023)]
[Notices]
[Pages 9524-9525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03071]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1048]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device 
Labeling Requirements; Unique Device Identification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by March 16, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0485. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device Labeling Requirements; Unique Device Identification

OMB Control Number 0910-0485--Revision

    This information collection supports implementation of section 
519(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 360i(f)), requiring the establishment of a unique device 
identification (UDI) system by FDA. Medical device labeling 
requirements governed by section 502 of the FD&C Act (21 U.S.C. 352) 
provide that every medical device and every device package bear a 
unique device identifier. Implementing regulations are found in part 
801, subpart B (21 CFR part 801, subpart B) (Labeling Requirements for 
UDI), including provisions for exceptions from UDI requirements (21 CFR 
801.30). Applicable regulations are also found in part 821 (21 CFR part 
821) (Medical Device Tracking Requirements); 21 CFR part 822 
(Postmarket Surveillance); part 814 (21 CFR part 814) (Premarket 
Approval of Medical Devices); and part 820 (21 CFR part 820) (Quality 
System Regulations), as well as regulations pertaining to in vitro 
device labeling, biological device product labeling, or any article 
subject to the device labeling provisions in section 502 of the FD&C 
Act. Products not in compliance with requirements set forth in the 
applicable statutory and regulatory authorities may be subject to 
enforcement action by FDA.
    For operational efficiency, we are revising the information 
collection to include burden that may be attributable to activities 
associated with provisions found in part 830 (21 CFR part 830), 
currently approved in OMB control number 0910-0720 and established 
through rulemaking on September 24, 2013 (0910-AG31). The regulations 
define relevant terms, identify specific data requirements, and 
incorporate global standards applicable to the use and discontinuation 
of a UDI. The regulations also provide for FDA accreditation of an 
issuing agency (21 CFR 830.110) and explain associated information 
collection activities including the establishment, maintenance, and 
disclosure of records. Finally, the regulations provide for 
administration of the Global UDI Database (GUDID) (part 830, subpart 
E), which specifies data that must be submitted to FDA to be made 
publicly available. Users of the GUDID will be able to use the device 
identifier portion of the UDI to query descriptive data about a 
specific device. The GUDID may be accessed on our website at https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/global-unique-device-identification-database-gudid.
    In the Federal Register of August 24, 2022 (87 FR 51989), we 
published a 60-day notice soliciting comment on the proposed collection 
of information. No comments were received. However, upon further review 
and evaluation, we have made adjustments to our estimated burden for 
the collection of information, as follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
    Part 801, subpart B: Labeling requirements for unique device        Number of       records per      Total annual         per          Total hours
                           identification                             recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requirements for a unique device identifier under part 830.........           6,199               51          316,149                1          316,149
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our figures are based on economic analysis from previous Agency 
rulemaking. We assume most burden associated with activities applicable 
to satisfying UDI requirements as prescribed by part 830 is accounted 
for in currently approved information collections. For example, 
information collection associated with medical device tracking 
provisions in part 821 is currently approved in OMB control number 
0910-0442; information collection associated with premarket approval of 
medical devices (part 814) is currently approved in OMB control number 
0910-0231. Similarly, information collection associated with our 
quality system regulation (part 820)

[[Page 9525]]

and information collection associated with our medical device recall 
authority (21 CFR part 810) is approved in OMB control numbers 0910-
0073 and 0910-0432, respectively. We assume burden respondents may have 
incurred as the result of any product relabeling, as well as one-time 
burden that respondents may have incurred resulting from integrating 
requirements into current tracking and labeling activities, has since 
been realized and is now accounted for among our currently approved 
inventory. Here, we are accounting for burden associated with UDI 
requirements prescribed by part 830 not otherwise included in currently 
approved collections and subject to general medical device labeling 
requirements established in part 801, subpart B. Because the PRA 
defines a recordkeeping requirement to include retained records, third-
party notifications and disclosures, and reporting to the Federal 
government as well as the public, we have accounted for these 
activities cumulatively, characterizing them as recordkeeping 
activities.

    Dated: February 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03071 Filed 2-13-23; 8:45 am]
BILLING CODE 4164-01-P