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HHS/FDA RIN: 0910-AF86 Publication ID: Spring 2009 
Title: Medical Device Reporting; Electronic Submission Requirements 
Abstract: The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulations to require that manufacturers, importers, and user facilities submit mandatory reports of medical device adverse events to the Agency in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency’s systems for collecting and analyzing postmarketing safety reports. The proposed change would help the Agency to more quickly review safety reports and identify emerging public health issues. 
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 803   
Legal Authority: 21 USC 352    21 USC 360    21 USC 360i    21 USC 360j    21 USC 371    21 USC 374   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/00/2009    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
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:
Madhusoodana Nambiar
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 5518, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-5837
Fax:301 847-8145
Email: madhusoodana.nambiar@fda.hhs.gov