FDA Extends Comment Deadline For Older Predicate Device List Proposal

Device stakeholders have another 30 days to comment on FDA’s proposal to post on its website cleared devices that demonstrated substantial equivalence to older predicate devices as part of its bid to encourage device makers to use new predicates. Though major device lobbies have yet to comment on the proposal, a prominent industry lawyer repeated his concerns that the idea would place unnecessary pressure on device manufacturers who in his view are already driven by the marketplace to find modern...