Zdrowie i gospodarka · 23/06/2000

FDA Classifies Devices to Relieve Upper Airway Obstruction into Class II with Special Controls

The FDA is classifying devices to relieve upper airway obstruction into class II with special controls, including a labeling and design control guidance document, in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.