0910-AI92 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Revocation of the Mutual Recognition of Pharmaceutical Good Manufacturing Practice, Medical Device Quality System Audit, and Certain Medical Device Product Evaluation Reports: U.S. and the E.C.

This final rule will revoke 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 FDA is taking this action because the existing regulations have either been superseded by the 2017 amended Mutual Recognition Agreement (pharmaceutical annex) or are unnecessary, and do not reflect current Agency practice.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage Undetermined No Deregulatory 21 CFR 26 5 U.S.C. 552 15 U.S.C. 1453 15 U.S.C. 1454 15 U.S.C. 1455 18 U.S.C. 1905 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360b 21 U.S.C. 360c 21 U.S.C. 360d 21 U.S.C. 360e 21 U.S.C. 360f 21 U.S.C. 360g 21 U.S.C. 360h 21 U.S.C. 360i 21 U.S.C. 360j 21 U.S.C. 360l 21 U.S.C. 360m 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 381 and 382 21 U.S.C. 383 21 U.S.C. 384e 21 U.S.C. 393 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 242l 42 U.S.C. 262 42 U.S.C. 264 42 U.S.C. 265 No NPRM 09/20/2024 89 FR 77062 NPRM Comment Period End 11/19/2024 Final Rule 11/00/2025 . No No Federal Local State No No No Yes Megan Andersen 0910 Food and Drug Administration FDA 310 428-5543 megan.andersen@fda.hhs.gov 10903 New Hampshire Avenue, Bldg. 32, Rm. 4373, Silver Spring MD 20993