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HHS/FDA RIN: 0910-AF82 Publication ID: Spring 2008 
Title: Postmarket Safety Reporting for Combination Products 
Abstract: The proposed rule would clarify the postmarket safety reporting requirements for combination products (combinations of a drug, device, and/or biological product). The proposed rule would provide a framework for the reporting of adverse events for combination products. The proposed rule would clarify the circumstances in which following one set of postmarket safety reporting regulations generally would meet the requirements of another set, and the circumstances in which these requirements would be supplemented with specific reporting provisions applicable to the other constituent part of the combination product. The regulation would ensure the consistency and appropriateness of postmarket safety reporting for combination products while avoiding the need for 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: Proposed 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    21 USC 352    21 USC 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
Timetable:
Action Date FR Cite
NPRM  11/00/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Leigh Hayes
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Office of Combination Products, Suite 200 (HFG-3), 15800 Crabbs Branch Way,
Rockville, MD 20855
Phone:301 427-1934
Fax:301 427-1935
Email: leigh.hayes@fda.hhs.gov