Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative

Abstract

The 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act granted the US Food and Drug Administration (FDA) regulatory authority over medical devices. Congress intended for FDA’s review requirements to correspond to the amount of information needed to provide ‘reasonable assurance of safety and effectiveness’ based on a device’s risk profile, establishing a three-tiered system for classifying devices: low risk, moderate risk and high risk.1 Low-risk devices are typically only subject to general controls (eg, good manufacturing practices) and exempt from premarket review. For moderate-risk devices, FDA additionally requires manufacturers to demonstrate ‘substantial equivalence’ to a previously authorised device, usually without clinical evidence of safety and effectiveness,2 through the 510(k) pathway (table 1). High-risk devices undergo the most rigorous regulatory review through the premarket approval (PMA) pathway,3 which typically requires evidence from clinical study(ies) demonstrating reasonable assurance of safety and effectiveness1,.