Industry: FDA’s proposed 510(k) changes more “benign” than feared
It looks like the medical device industry is breathing a collective sigh of relief after its initial review of the FDA’s proposed changes to its so-called fast-track 510(k) clearance rules. However some serious worries remain.
“[The] proposals are more benign than many had feared,” health care investment bank Leerink Swann’s analyst Rick Wise said in a mostly upbeat e-mail to investors Wednesday.
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