The effect of recent FDA legislation on contraceptive development and safety.
By law, medical devices with a potential hazard to health or safety are not subject to the same premarket approval and scientific review processes as drugs. Manufacturers of intrauterine contraceptive devices and new instruments or devices for surgical sterilization will be required to present evidence of their products' effectiveness and safety to a United States Food and drug Administration advisory panel made up of physicians and scientists from outside the agency. Hazards previously experienced with contraceptive devices and requirements for testing new devices are described.
D005260:Female; D006801:Humans; D007434:Intrauterine Devices; D020706:Laparoscopes; D007883:Legislation, Medical; D013245:Sterilization, Reproductive / Q000295:instrumentation*; D013246:Sterilization, Tubal / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration