FDA obstetrics-gynecology device classification report.

PIP: A tentative classification of obstetrical and gynecological devices, proposed by the Panel on Review of Obstetrical and Gynecological Devices of the Bureau of Medical Devices and Diagnostic Products of the Food and Drug Administration, is presented. The devices are classified, for regulatory purposes, under 3 general categories (scientific review, specific standards, and general control) as diagnostic, surgical monitoring, prosthetic, and therapeutic devices. The development of the categoreal scheme is discussed. Comments from obstetrician-gynecologists and concerned individuals are invited.^ieng