Document ID: FDA-2016-N-2544-0013
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quality System Regulation
Posted Date: 2022-12-13T05:00Z

[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76199-76200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27023]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2544]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Quality System 
Regulation

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 January 12, 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 0910-0073. 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 Devices: Current Good Manufacturing Practice Quality System 
Regulation--21 CFR part 820

OMB Control Number 0910-0073--Extension

    As authorized under section 520(f) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360j(f)), the Secretary of the 
Department of Health and Human Services has issued regulations 
requiring that the methods used in, and the facilities and controls 
used for, the manufacture, preproduction design validation (including a 
process to assess the performance of a device, but not including an 
evaluation of the safety and effectiveness of a device), packing, 
storage, and installation of a device conform to current good 
manufacturing practice (CGMP) and assure that the device will be safe 
and effective and otherwise in compliance with the FD&C Act.
    The quality system regulation (QSR) under part 820 (21 CFR part 
820) sets forth CGMP requirements governing the design, manufacture, 
packing, labeling, storage, installation, and servicing of all finished 
medical devices intended for human use. The requirements cover 
purchasing and service controls, clarify recordkeeping for device 
failure and complaint investigations, clarify requirements for 
verifying/validating production processes and process or product 
changes, and clarify requirements for product acceptance activities, 
quality data evaluations, and corrections of nonconforming product/
quality problems. In the Federal Register of February 23, 2022 (87 FR 
10119), we proposed to incorporate by reference International 
Organization for Standardization 13485 (ISO 13485): Medical devices--
Quality Management Systems--Requirements for Regulatory Purposes, the 
2016 edition, to the QSR (RIN 0910-AH99), to align implementation of 
requirements.
    Information collection under the QSR is intended to assist FDA in 
assuring the safety of medical devices. Requirements include 
documenting the establishment of procedures and identifying required 
records that assist FDA in determining whether firms are in compliance 
with CGMP. In particular, for example, compliance with CGMP design 
control requirements should decrease the number of design-related 
device failures that have resulted in deaths and serious injuries. 
Records must be made available for review or copying during FDA 
inspection. The regulations in part 820 apply to approximately 29,424 
respondents, based on current data within our device registration and 
listing database.
    In the Federal Register of August 22, 2022 (87 FR 51433), we 
published a 60-day notice soliciting comment on the proposed collection 
of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                    Number of                     Average burden
   21 CFR part 820; required       Number of       records per     Total annual         per         Total hours
            records              recordkeepers     recordkeeper       records      recordkeeping
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Quality System Requirements--            29,424                1          29,424              83       2,442,192
 Subpart B....................
Design Controls--Subpart C....           29,424                1          29,424             132       3,883,968
Document Controls--Subpart D..           29,424                1          29,424              11         323,664
Purchasing Controls--Subpart E           29,424                1          29,424              28         823,872
Identification and                       29,424                1          29,424               2          58,848
 Traceability--Subpart F......
Production and Process                   29,424                1          29,424              31         912,144
 Controls--Subpart G..........
Acceptance Activities--Subpart           29,424                1          29,424               6         176,544
 H............................
Nonconforming Product;                   29,424                1          29,424              23         676,752
 Corrective and Preventative
 Action--Subparts I And J.....
Labeling and Packaging                   29,424                1          29,424               3          88,272
 Controls--Subpart K..........
Handling, Storage,                       29,424                1          29,424              15         441,360
 Distribution, and
 Installation--Subpart L......
Records--Subpart M............           29,424                1          29,424              10         294,240
Servicing--Subpart N..........           29,424                1          29,424               3          88,272
Statistical Techniques--                 29,424                1          29,424               1          29,424
 section 820.250--Subpart O...
                               ---------------------------------------------------------------------------------
    Total.....................  ...............  ...............  ..............  ..............      10,239,552
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 76200]]

    Our estimated burden for the information collection reflects an 
overall increase of 1,217,800 hours. We made this adjustment to 
correspond with an observed increase in submissions relating to medical 
devices and an increase in respondents in the medical device industry 
since last OMB review and approval of the information collection.

    Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27023 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P