FDA Unveils Proposal For Streamlined De Novo Reviews
This article was originally published in The Gray Sheet
Despite statutory constraints, FDA is hoping to trim as many as 90 days off the total review process for de novo petitions.
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FDA granted more than double the number of de novo petitions in FY 2013 compared to past years, reflecting the availability of the direct de novo pathway recently established by Congress. De novo petitions allow a device that FDA deems to be low-to-moderate risk but without a clear predicate to enter the market without requiring a PMA.
FDA releases an update of its draft de novo classification guidance Aug. 14 to comport with FDA Safety and Innovation Act, and permit manufacturers to submit de novo applications for review without a preceding 510(k) submission.
Industry is skeptical of FDA claims that the plan mapped out in a recent draft guidance on de novo petitions will speed the review process for devices that aren’t a good fit for either the 510(k) or PMA programs.