Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases
These guidelines address the preclinical and clinical testing of female barrier contraceptive devices also intended to prevent transmission of sexually transmitted diseases (STDs), including Acquired Immunodeficiency Syndrome (AIDS). The guidelines were developed on August 25, 1989, at an open public meeting of the Obstetrics-Gynecology Devices Panel (the Panel) as a collaborative effort of experts from the Food and Drug Administration (FM), the National Institute of Child Health and Human Development (NICHD), the Centers for Disease Control (CDC), and the Panel, involving substantial interactive dialogue with the public audience, as well.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.