2024-23701. Medical Devices; Quality System Regulation Amendments; Correction

Document Headings

Document headings vary by document type but may contain the following:

1. the agency or agencies that issued and signed a document
2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
3. the agency docket number / agency internal file number
4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions

See the Document Drafting Handbook for more details.

Department of Health and Human Services

Food and Drug Administration

1. 21 CFR Part 820
2. [Docket No. FDA-2021-N-0507]
3. RIN 0910-AH99

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correction.

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 § 820.3 (21 CFR 820.3) but the definition for “batch” or “lot” was inadvertently omitted from the codified portion of § 820.3 in the final rule. FDA is, therefore, correcting the codified for § 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:

§ 820.3

[Corrected]

1. On page 7524, in amendment number 4, in the first column, in paragraph (a) of § 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.