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'Quik' Review Program Builds On US FDA eSubmission Efforts

 
• By David Filmore

The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.

train fast run on railway track in sunny day

US FDA is unveiling a new pilot program that will encourage companies to submit 510(k)s electronically with the promise of a quicker review time.

FDA Commissioner Scott Gottlieb unveiled the plan Sept. 5 at the Medical Device Innovation Consortium annual public forum in Washington, DC. "This new approach is like a TurboTax for information submitted in 510ks," Gottlieb said at the MDIC meeting

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