FDA REFORM INDUSTRY CONSENSUS DOCUMENT INCLUDES TWO 510(K) REVIEW OPTIONS; MANUFACTURERS OTHERWISE UNIFIED AS CONGRESS FINALIZES REFORM MEASURES
This article was originally published in The Gray Sheet
A consensus FDA reform proposal released by major device industry associations Oct. 13 suggests two alternative paths to ensuring that 510(k) devices can be marketed within 90 days after submitting a premarket notification. The relatively minor differences of opinion on changes to 510(k) requirements represent the only division in what is otherwise a unified industry front on the legislative proposal.
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