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Home » 510(k) Premarket Clearance May Land Some Devicemakers in Court
510(k) Premarket Clearance May Land Some Devicemakers in Court
August 3, 2006
The time and expense required to get an FDA premarket approval (PMA) for a device may be worth it, as some devicemakers are finding themselves in court after taking the more streamlined 510(k)approval route, compliance lawyers say.