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HHS/FDA RIN: 0910-AC31 Publication ID: Spring 2002 
Title: ●Postmarket Surveillance 
Abstract: The Food and Drug Administration (FDA) is implementing a final rule for the postmarket surveillance provisions of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 822 
Legal Authority: 21 USC 331; 21 USC 352; 21 USC 360i; 21 USC 360l; 21 USC 371; 21 USC 374; ... 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/29/2000  65 FR 52376 
NPRM Comment Period End  11/27/2000   
Final Action  06/00/2002   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Joseph M. Sheehan
Chief, Regulations Staff
Department of Health and Human Services
Food and Drug Administration
HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive,
Rockville, MD 20850
Phone:301 827-2974
Fax:301 594-4765
Email: joseph.sheehan@fda.hhs.gov

 
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