Abstract
New Food and Drug Administration regulations designed to protect human subjects involved in clinical testing of experimental devices require obtaining consent from each experimental subject after he or she is informed of possible risks, and reporting of any unanticipated adverse effects to the FDA within 20 days. Responsibility for adhering to the standards is divided between the manufacturer, who is forbidden to make a profit from clinical trials, the clinical investigator, and the Institutional Review Board. Implants intended to remain in the body 30 days or more are specifically included as significant risk devices, and this ruling will affect research on many devices designed to be implanted in the fallopian tubes and vas deferens and on IUDs not containing physiologically active components. Many contraceptive devices besides implants are affected, as are all instruments and most reagents used in prenatal diagnostic testing. The manufacturer is required to file a final report on the investigation to the FDA within 6 months of completion of tests. Once the FDA has ruled on whether a new device may be marketed, the agency has the authority to release a detailed summary of the clinical trials.
Published Version
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