Zdrowie i gospodarka · 29/09/1998

FDA Amends Regulations for Medical Device Establishment Registration and Device Listing

The US Food and Drug Administration (FDA) is updating its rules for medical device manufacturers and distributors to align with changes to the Federal Food, Drug, and Cosmetic Act, as mandated by the Food and Drug Modernization Act of 1997. The FDA is also publishing a proposed rule to finalize the changes, following public comment and feedback.