Document Detail


Female condom technology: new products and regulatory issues.
MedLine Citation:
PMID:  21397088     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Like male condoms, female condoms (FCs) provide protection against unplanned pregnancy and most sexually transmitted infections including HIV. The first FC made by the Female Health Company was approved by the US Food and Drug Administration (USFDA) in 1993. Since 2000, several different types of FCs have become available or are in development to lower the cost and/or improve acceptability. Although similar in function, new FCs often differ in design and materials. Classified as Class III medical devices by the USFDA, FCs have a regulatory process that is more complex than that for male condoms. This, coupled with the lack of an international standard to verify the quality of new devices, has hindered new products gaining regulatory approvals and entering the market. We review the existing regulatory pathway for FCs, the progress made in developing standards specifically for FCs and the FCs available now or in development, including their current status regarding approval.
Authors:
Mags Beksinska; Jenni Smit; Carol Joanis; Margaret Usher-Patel; William Potter
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Publication Detail:
Type:  Journal Article     Date:  2010-09-15
Journal Detail:
Title:  Contraception     Volume:  83     ISSN:  1879-0518     ISO Abbreviation:  Contraception     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-03-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0234361     Medline TA:  Contraception     Country:  United States    
Other Details:
Languages:  eng     Pagination:  316-21     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Elsevier Inc. All rights reserved.
Affiliation:
Maternal, Adolescent and Child Health (MatCH), Department of Obstetrics and Gynaecology, University of the Witwatersrand, Overport 4091, South Africa.
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