FDA Aims To Smooth Premarket Review process | Bloomberg BNA.

Wednesday, August 22, 2012

FDA Aims To Smooth Premarket Review process

by Nathaniel Weixel

In the world of medical device reviews, timing is everything. Device manufacturers often claim FDA does not review their premarket applications quickly enough. For its part, FDA has said some of the blame lies with the companies that submit applications missing key information. It’s a time consuming process to keep sending companies requests for more information. FDA officials have even said they’ve come across applications that aren’t even written in English.

In an effort to improve overall review times and enhance the quality of submissions, FDA in the past month has released a pair of draft guidances for industry and agency staff. The documents are pretty similar, but each covers a different type of premarket review. One addresses the idea of a “refusal to accept” policy for 510(k) applications, and the other addresses essentially the same idea for premarket approval (PMA) applications. The 510(k) process is how most low and moderate-risk devices reach the market, and requires only that they be proven substantially equivalent to a device already being sold. PMAs generally require clinical trials, and are for high risk devices.

Both guidances outline the minimum requirements manufacturers must include in the respective premarket applications. The PMA guidance includes two checklists: acceptance criteria and filing criteria. If the manufacturer doesn’t meet the acceptance criteria, the FDA reviewer can send the application back within 15 days without having to look at any other components. The 510(k) “refusal to accept” policy is similar– if the manufacturer doesn’t meet specific criteria (outlined in a checklist), the reviewer can send it back and ask for the correct information before filing the application for a more substantial review.

Both guidances are still just drafts with comment periods, but FDA hopes they will lead to a much more efficient use of agency resources and a higher quality of device submissions. Comments on the 510(k) guidance are due Sept. 27, and comments on the PMA guidance are due Sept. 14.

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