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HHS/FDA RIN: 0910-AF82 Publication ID: Fall 2015 
Title: 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.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 4, subpart B     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 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   
Legal Deadline:  None
Action Date FR Cite
NPRM  10/01/2009  74 FR 50744   
NPRM Comment Period End  12/30/2009    
Final Action  04/00/2016 
Additional Information: Includes Retrospective Review under E.O. 13563 with small business burden reduction.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
John Barlow Weiner
Associate Director for Policy
Department of Health and Human Services
Food and Drug Administration
Office of Combination Products, 10903 New Hampshire Avenue, W032, Room 5130,
Silver Spring, MD 20993
Phone:301 796-8941