Zdrowie i gospodarka · 25.02.1998
Medical Devices; Postmarket Surveillance; Guidance Documents; Availability
The Food and Drug Administration (FDA) is announcing the availability of three guidance documents on postmarket surveillance of medical devices. These guidance documents are being issued in order to facilitate the implementation of the postmarket surveillance provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997. FDA will issue further guidance in the near future.