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HHS/FDA RIN: 0910-AF21 Publication ID: Spring 2006 
Title: Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and Condoms With Spermicidal Lubricant 
Abstract: The classification regulations for male 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 compliance with the recommendations in the guidance, or with some equivalent means of addressing the identified issues 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 801. The rule will demonstrate how the Agency is moving forward to meet 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; 21 CFR 884.5310 
Legal Authority: 21 USC 360c 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/14/2005  70 FR 69102 
Final Action  12/00/2006   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Nancy Pirt
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6248
Fax:301 847-8145
Email: nancy.pirt@fda.hhs.gov

 
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