CLASSIFICATION REQUESTS FOR DE NOVO LOW-RISK DEVICES TO BE ADDRESSED IN FDA GUIDANCE; FINAL 510(K) PARADIGM POLICY SLATED FOR PUBLICATION FEB. 20
This article was originally published in The Gray Sheet
Executive Summary
FDA plans to develop guidance for manufacturers on submission of requests for Class I or Class II status of low-risk devices that lack a predicate. The guidance would implement a provision of the FDA Modernization Act aimed at preventing devices without substantially equivalent predicates from defaulting into Class III.