Zdrowie i gospodarka · 24/01/2000

FDA Modernization Act of 1997; Guidance on Medical Device Tracking; Availability

The Food and Drug Administration (FDA) has released a revised guidance document on medical device tracking, replacing a previous version from February 12, 1999, and outlining manufacturers' and distributors' responsibilities under the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).