[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Rules and Regulations]
[Page 82945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23701]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 820

[Docket No. FDA-2021-N-0507]
RIN 0910-AH99


Medical Devices; Quality System Regulation Amendments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is correcting 
a final rule that appeared in the Federal Register on February 2, 2024. 
In that final rule, FDA amended the device current good manufacturing 
practice (CGMP) requirements of the Quality System (QS) regulation to 
harmonize and modernize the device CGMP. FDA is correcting an editorial 
error that inadvertently omitted a definition in the codified of the 
final rule. This action is editorial in nature and is intended to 
ensure the accuracy and clarity of the Agency's regulations.

DATES: Effective February 2, 2026.

FOR FURTHER INFORMATION CONTACT: Laurie Sternberg, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5517, Silver Spring, MD 20993-0002, 240-
402-0425.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 2, 2024 
(89 FR 7496), FDA published a final rule that amended the device CGMPs 
requirements in 21 CFR part 820. The preamble indicated that the 
definition for ``batch'' or ``lot'' was set forth at Sec.  820.3 (21 
CFR 820.3) but the definition for ``batch'' or ``lot'' was 
inadvertently omitted from the codified portion of Sec.  820.3 in the 
final rule. FDA is, therefore, correcting the codified for Sec.  820.3 
to include the definition of ``batch'' or ``lot'' as was intended and 
to be consistent with the preamble of the final rule.
    In FR Doc. 2024-01709 appearing on page 7524 in the Federal 
Register of Friday, February 2, 2024 (89 FR 7496), the following 
correction is made:


Sec.  820.3  [Corrected]

0
1. On page 7524, in amendment number 4, in the first column, in 
paragraph (a) of Sec.  820.3, the definition for ``Batch or lot'' is 
added in alphabetical order to read as follows:
    ``Batch or lot means one or more components or finished devices 
that consist of a single type, model, class, size, composition, or 
software version that are manufactured under essentially the same 
conditions and that are intended to have uniform characteristics and 
quality within specified limits.''

    Dated: October 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-23701 Filed 10-11-24; 8:45 am]
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