Guidance Details FDA’s Assessment of its PMA Performance
10/08/2003
Federal Register Notice: FDA is making available a guidance entitled Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications: Effect on FDA Review Clock and Performance Assessment. This guidance describes how FDA will assess its performance in the premarket approval application program relative to the goals that accompany the authorization of medical device user fees. To download this guidance, click here. To view this notice, click here.
