FDA Guidance Reformats Annual Reports for PMA Products

After a device receives PMA approval, its manufacturer must file a report annually with FDA updating it on manufacturing, design, and labeling changes, among other things. For years, it appeared, very little was ever done with this information. But in this era of heightened postmarket surveillance, CDRH would like to see annual reports reformatted to better highlight potential safety issues. Today, it released a draft guidance outlining how it would like to see annual reports formatted. The public has 90 days to submit comments.