More PMA Devices Need Postapproval Studies

CDRH has been requiring postapproval studies in granting premarket approval to Class III devices more often over the past two years, according to figures provided by the center. The increase is not dramatic and should not be interpreted as a growing burden on industry, Danica Marinac-Dabic, director of CDRH’s Division of Epidemiology, said. However, the FDA as a whole is focusing more on postapproval studies than it did in the past.
Clinical Trials Advisor