D duinyk Involved In Discussions Aug 20, 2019 #1 Aug 20, 2019 #1 Please what will be the possible contents of a 510k Q sub? Not just general content of Q-subs. Anyone has a template? Thanks
Please what will be the possible contents of a 510k Q sub? Not just general content of Q-subs. Anyone has a template? Thanks
Ronen E Problem Solver Staff member Moderator Aug 20, 2019 #2 Aug 20, 2019 #2 The specific content will depend on your own case specifics. Writing a Pre-Submission to the FDA