Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
fda-device · Food and Drug Administration · Rule · Published 2026-02-19 · Effective 2026-03-23 · 91 FR 7825
Document
Document number
2026-03286
Federal Register citation
91 FR 7825
CFR reference
21 CFR 26
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2026-02-19
Effective date
2026-03-23
HHS docket
Docket No. FDA-2024-N-4016
Abstract
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule revoking the regulations entitled "Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community." FDA is taking this action because the regulations at 21 CFR part 26 have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.