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HHS/FDA RIN: 0910-AF82 Publication ID: Fall 2011 
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 provide a framework for the reporting of adverse events for combination products. The rule would clarify that a combination product is subject primarily to the reporting requirements associated with the type of marketing application under which the product is approved or cleared. In addition, the rule identifies additional reporting provisions that must be complied with if applicable. 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  06/00/2012    
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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