FDA Unveils Proposal For Streamlined De Novo Reviews

Article preview from "The Gray Sheet"- October 10, 2011

Despite statutory constraints, FDA is hoping to trim as many as 90 days off the total review process for de novo petitions.

FDA Unveils Proposal For Streamlined De Novo Reviews

Article preview from "The Gray Sheet"- October 10, 2011

The agency outlined its proposed administrative changes in a Sept. 30 draft guidance on the de novo review program.

The plan would allow firms to submit a “pre de novo submission” so FDA can analyze earlier whether the device is suitable for the de novo process. If eligible, firms could then submit a 510(k) and de novo petition concurrently, FDA proposes.

The de novo program, created in 1997, is meant for low- to moderate-risk devices that cannot be found substantially equivalent to anything already on the market.

These products are legally class III devices, but the de novo program was established so that products of relatively low risk would not have to go through costly and lengthy pre-market approval (PMA) reviews.

Currently, companies first need to submit a 510(k), wait for a not-substantially-equivalent determination and then submit a de novo petition.

 

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