Medical Devices; Anesthesiology Devices; Classification of Devices to Relieve Upper Airway Obstruction
Information
Type
Rule
Regulated products
Medical Devices
Published
June 23, 2000
Last updated
June 23, 2000
Description
Document number 00-15864. The Food and Drug Administration (FDA) is classifying devices to relieve upper airway obstruction into class II (special controls). The special control that will apply to this device is a labeling and design control guidance document. This action is being taken in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II in order to provide a reasonable assurance of the safety and effectiveness of the device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)