Tag:
de novo
Latest Headlines
Latest Headlines
FDA unveils guidance on how PMAs, de novo submissions are reviewed
Unpredictable is one term devicemakers have used to describe the premarket approval and de novo submission process with the FDA. But now, a ray of hope for some clarity.
FDA unveils streamlined de novo guidelines
The FDA has proposed new guidelines for the de novo clearance process that the agency says could shave 90 days off approval period of some devices. Currently, only devices that have already been
