Zdrowie i gospodarka · 13/12/2002

FDA Proposes Reclassification of Arrhythmia Detector and Alarm from Class III to Class II

The FDA is proposing to reclassify the arrhythmia detector and alarm from a Class III device requiring premarket approval to a Class II device with special controls, following new information and petitions submitted under the Federal Food, Drug, and Cosmetic Act, and in response to the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.