Notice2023-03071
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Requirements; Unique Device Identification
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 14, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 30 (Tuesday, February 14, 2023)</title>
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[Federal Register Volume 88, Number 30 (Tuesday, February 14, 2023)]
[Notices]
[Pages 9524-9525]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03071]
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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.
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#613133203215000707210705004f0909124f060e17"><span class="__cf_email__" data-cfemail="401012011334212626002624216e2828336e272f36">[email protected]</span></a>.
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 <a href="https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/global-unique-device-identification-database-gudid">https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/global-unique-device-identification-database-gudid</a>.
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\
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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
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Requirements for a unique device identifier under part 830......... 6,199 51 316,149 1 316,149
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\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
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