The Ear,Nose,and Throat Devices Classification Panel of the Food and Drug Administration

The passage into law in 1976 of the Medical Device Amendments authorized the FDA to regulate the safety and efficacy of medical devices. The effects of this regulation are contrasted with the mode of entry of medical devices onto the market prior to 1976. The structure and operation of Ear, Nose, and Throat Devices Classification Panel is described briefly. Continued input from otolaryngologists and allied professionals is encouraged.