Which FDA route a device qualifies for, 510(k), De Novo or PMA
How FDA premarket routes divide between 510(k), De Novo and PMA, with the criteria, contents and review timeframes set by 21 CFR parts 807 and 814.
Tag: pathway
1 post
1 post
How FDA premarket routes divide between 510(k), De Novo and PMA, with the criteria, contents and review timeframes set by 21 CFR parts 807 and 814.