FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; OBSTETRICAL AND GYNECOLOGICAL DEVICES; CLASSIFICATION OF THE EXTERNAL CONDOM FOR ANAL INTERCOURSE OR VAGINAL INTERCOURSE

WASHINGTON, May 8 -- Food and Drug Administration has issued a rule called: Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse.

The rule was published in the Federal Register on May 8 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the external condom for anal intercourse or vaginal intercourse into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the external condom for anal intercourse or vaginal intercourse. We are taking t...