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HHS/FDA RIN: 0910-AF82 Publication ID: Fall 2013 
Title: Postmarket Safety Reporting for Combination Products 
Abstract: 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, subchapter B (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271 
Legal Deadline:  None
Action Date FR Cite
NPRM  10/01/2009  74 FR 50744 
NPRM Comment Period End  12/30/2009   
Final Action  06/00/2014   
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 
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, W032, Room 5130, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-8930
Fax:301 847-8619

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