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HHS/FDA RIN: 0910-AF86 Publication ID: 2012 
Title: Medical Device Reporting; Electronic Submission Requirements 
Abstract: FDA is amending its postmarketing medical device reporting (MDR) regulations to require manufacturers and importers to submit electronic reports of individual medical device adverse events to the agency. Electronic submission of MDRs will improve the agency's systems for collecting and analyzing postmarket MDRs. Also, this change is expected to result in significant burden reductions in reporting and recordkeeping for reporting entities. 
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 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  08/21/2009  74 FR 42203   
NPRM Comment Period End  11/19/2009    
Final Rule  02/00/2013 
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
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