Federal Register Notice: FDA is making available a guidance for industry entitled Premarket Approval Application Modular Review. This guidance is intended to provide industry and FDA staff with information about the content of a modular PMA and the procedures for submitting and reviewing a modular PMA. It supersedes and replaces the guidance document entitled Guidance for the Medical Device Industry on PMA Shell Development and Modular Review issued 11/6/98. To download this guidance, click here. To view this notice, click here.
