View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AF21 Publication ID: Fall 2008 
Title: Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 
Abstract: The classification regulation for condoms would be amended to specify a labeling guidance document as a special control for condoms made from natural rubber latex. The new special control guidance document would identify issues presented by these devices, and would provide detailed recommendations for labeling to address these issues. FDA believes that addressing the issues identified in the guidance, either by following the recommendations in the guidance or by some other means that provide equivalent assurances of safety and effectiveness, together with the general controls, will provide a reasonable assurance of the safety and effectiveness of these devices. These labeling recommendations are also consistent with the labeling requirements of 21 CFR part 801. The rule will demonstrate how the Agency is addressing the congressional directive of Public Law 106-554 that FDA review condom labeling to assure that the information regarding the overall effectiveness or lack of effectiveness of condoms in preventing sexually transmitted diseases is medically accurate. 
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 884.5300   
Legal Authority: 21 USC 360c   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/14/2005  70 FR 69102   
NPRM Comment Period End  02/13/2006    
Final Action  12/00/2008    
Regulatory Flexibility Analysis Required: Yes  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: Yes 
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