On April 11ththe FDA extended the comment period for call for comments on how to shift industry and agency focus towards the development and use of more modern predicate devices for determinations of Substantial Equivalence (following the Medical Device Safety Action Plan; see my previous post for details). The docket will be open for comments until May 22, 2019. 31 comments had been received as of midnight on April 13th. My read of several of these suggests the FDAs proposal is quite controversial, thus prompting the additional comment period. 

Text Copyright © 2019 Katrina Rogers