Obstetrical and Gynecological Devices; Proposed Classification of Female Condoms

Streszczenie

The Food and Drug Administration (FDA) is proposing to classify the preamendments female condom intended for contraceptive and prophylactic purposes. Under this proposal, the preamendments female condom would be classified into class III (premarket approval). The agency is publishing in this document the March 7, 1989, recommendations of FDA's Obstetrics-Gynecology Devices Panel (the Panel) regarding the classification of this device. After considering public comments on this classification proposal, FDA will publish a final rule classifying this device. This action is being taken to establish regulatory controls that will provide reasonable assurance of the safety and effectiveness of this device.