Zdrowie i gospodarka · 5/8/2013
510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing the public meeting entitled "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device." The focus of this meeting is FDA's interpretation of its regulations concerning when a modification made to a 510(k)-cleared device requires a new 510(k) submission.