Condition of Approval Studies: FDA Takes A New Look

Medical device companies spend considerable time and resources conducting clinical studies to demonstrate the “reasonable assurance of safety and

effectiveness” that is needed to gain approval from the Food and Drug Administration (FDA) of a premarket approval application (PMA). But when FDA’s Center for Devices and Radiological Health (CDRH) decides to approve the company’s PMA, it often does so with “strings attached” -an additional clinical study referred to as a “condition of approval.” In other words, the “reasonable assurance” already demonstrated is not unequivocal. FDA

has identified additional questions that the agency feels need to be studied after marketing to provide continued assurance of safety and effectiveness.