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HHS/FDA RIN: 0910-AF88 Publication ID: 2012 
Title: Electronic Registration and Listing for Devices 
Abstract: This rule would set forth requirements for electronic registration and listing for medical devices, while continuing to offer an avenue of registration and listing for those companies without Web access. This rule is intended to allow industry greater flexibility and the use of the latest in technology for information collection. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 807   
Legal Authority: PL 110-85    PL 107-188, sec 321    PL 107-250, sec 207    21 USC 360(a) to 360(j)    21 USC 360(p)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/26/2010  75 FR 14510   
NPRM Comment Period End  06/24/2010    
Final Rule  08/02/2012  77 FR 45927   
Additional Information: Includes Retrospective Review under E.O.13563.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
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