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GUIDANCE DOCUMENT

Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases April 1990

Final

Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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

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.