Medical Devices; Quality System Regulation Amendments; Correction
fda-device · Food and Drug Administration · Rule · Published 2024-10-15 · Effective 2026-02-02 · 89 FR 82945
Document
Document number
2024-23701
Federal Register citation
89 FR 82945
CFR reference
21 CFR 820
Type
Rule
Action
Final rule; correction.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2024-10-15
Effective date
2026-02-02
HHS docket
Docket No. FDA-2021-N-0507
Abstract
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.