Associate Director for Policy

0910-AF82 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Postmarket Safety Reporting for Combination Products

The rule would describe the postmarket safety reporting requirements for combination products (combinations of a drug, device, and/or biological product). The rule would clarify that a combination product is subject to the reporting requirements associated with the type of marketing application under which the product is approved, licensed, or cleared, and to certain additional, specified reporting requirements depending on the types of constituent parts (drug, device, or biological product) of which it is comprised. The regulation would ensure the consistency and appropriateness of postmarket safety reporting for combination products while minimizing duplicative reporting requirements.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 4, subpart B 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360bbb 21 U.S.C. 360c to 360f 21 U.S.C. 360h to 360j 21 U.S.C. 360l 21 U.S.C. 360hh to 360ss 21 U.S.C. 371(a) 21 U.S.C. 372 to 374 21 U.S.C. 379e 21 U.S.C. 381 21 U.S.C. 394 42 U.S.C. 216 42 U.S.C. 262 42 U.S.C. 263a 42 U.S.C. 264 42 U.S.C. 271 No NPRM 10/01/2009 74 FR 50744 NPRM Comment Period End 12/30/2009 Final Action 12/00/2016 Includes Retrospective Review under E.O. 13563 with small business burden reduction. No Businesses State Undetermined No Yes John Weiner Barlow Associate Director for Policy 0910 Food and Drug Administration FDA 301 796-8941 john.weiner@fda.hhs.gov Office of Combination Products, 10903 New Hampshire Avenue, W032, Room 5130, Silver Spring MD 20993