PMA Submissions: Navigating Quality in Premarket Approval | Scilife

The United States Food and Drug Administration (FDA) is the regulatory body responsible for the safety and efficacy of medical devices in the United States. The 510(k) clearance is their classic premarket clearance for Class II medical devices that most of us are probably familiar with. The 510(k) demonstrates that devices are substantially equivalent to similar devices on the market, clearing them for sale in the US. Class III devices, on the other hand, are subject to the most stringent type..