Zdrowie i gospodarka · 26/03/2010

FDA Proposes Updates to Medical Device Registration and Listing Regulations

The Food and Drug Administration (FDA) is proposing to update its regulations for medical device establishment registration and listing, following recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) enacted in 2007. The proposed changes aim to facilitate electronic submission of registration and listing information and align with the FDA's Unified Registration and Listing System (FURLS).