In cooperation with the Bureau of Medical Devices of the Food and Drug Administration, JAMA MEDICAL NEWS is planning to list all class III medical devices that have received premarket approval from the bureau. This list will be updated monthly.
Notice of approval of these devices also is published in the Federal Register. As of Nov 26,1979, forty-five class III devices had been approved.
The bureau's regulatory purview covers three categories of devices. Class I, the least restrictive category, requires only general controls on the devices, such as quality assurance in the manufacturing of products and prohibition of false or misleading labeling or advertising. Products in this class include surgical instruments, stethoscopes, and tongue depressors.
The class II category, somewhat more restrictive, requires that devices of a certain type live up to performance standards (such as safe current limits or material biocompatibility) that have been developed for devices of that