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HHS/FDA RIN: 0910-AG51 Publication ID: Spring 2011 
Title: Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices 
Abstract: The purpose of this proposed rule is to require the submission of a premarket approval application or notice of completion of a product development protocol for four class III preamendments devices. This regulation will provide FDA with more oversight concerning the four class III device types that currently can be marketed via less stringent premarket notification procedures. If finalized, this regulation will require premarket approval for the four class III device types within 90 days of the issuance of a final rule or within 30 months after final classification of the device, whichever is later. The four devices are ventricular bypass (assist) device; pacemaker repair or replacement material; female condom; and transilluminator for breast evaluation. The proposed rule also publicizes advisory panel findings on the four device types and provides an opportunity to request a change in classification of the devices based on new information. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 870    21 CFR 884    21 CFR 892   
Legal Authority: 21 USC 360ccc-1 and 360ccc-2    21 USC 371(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/25/2010  75 FR 52294   
NPRM Comment Period End  11/30/2010    
Final Action  To Be Determined    
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