Lawyers: FDA Proposed De Novo Rule Might Discourage Developers

Four device industry lawyers said the de novo rule proposed by FDA Dec. 4 could discourage product developers from entering the de novo pathway by making the route resemble the beefier premarket approval (PMA) process, which is typically reserved for higher-risk devices. The de novo pathway is intended for lower-risk medical devices for which there is no predicate device to be compared. The lawyers specifically criticize the rule’s allowance of premarket manufacturing inspections; new grounds for denying de novo clearance;...