Third-Party Review: FDA Seeks Tangible 510(k) Results Over Next Three Years
Under a new plan and draft guidance issued by US FDA, the agency is hoping to streamline and improve its third-party review program. The goal is to spend substantially less FDA resources re-reviewing low-to-moderate risk 510(k) applications that go through the program and allow products to enter market sooner.
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US FDA Commissioner Scott Gottlieb and the agency’s new diagnostics office chief Tim Stenzel want to use a combination of pre-certification, assistance from third-party reviewers and review exemptions to help quickly clear the tsunami of molecular-based diagnostic tests expected to be submitted to FDA for review in the next several years.
The standard US FDA fee for a 510(k) submission will increase 124% in FY 2018, but small companies will see a much more moderate 12% jump. Other fees will increase by between 30%-40% in the coming fiscal year. And, perhaps, the biggest change will be for de novo submissions, which will have a user fee for the first time. FDA issued its inflation-adjusted user-fee schedule following the recent enactment of MDUFA IV.