FDA Says User Fee Proposal Could Shorten Total Pre-market Review Times

Article preview from "The Gray Sheet"- May 9, 2011

FDA's first crack at an industry user fee reauthorization proposal did not change review goals for 510(k)s, but did suggest some new processes to shorten overall review times for 510(k)s and PMAs alike.

FDA Says User Fee Proposal Could Shorten Total Pre-market Review Times

Article preview from "The Gray Sheet"- May 9, 2011

FDA's first crack at an industry user fee reauthorization proposal did not change review goals for 510(k)s, but did suggest some new processes to shorten overall review times for 510(k)s and PMAs alike.

During April 13 negotiations with industry, the agency proposed to continue attempting to review 90% of 510(k)s within 90 FDA days and 98% of 510(k)s within 150 FDA days.

Instead of changing the 510(k) review goals, FDA proposed new "program efficiencies." For one, the agency is considering implementing a new "refuse-to-accept" policy that would screen out incomplete pre-market submissions from the start.

CDRH leadership has been pressing industry to take more responsibility for the quality of pre-market submissions and the subsequent delays that poor submissions can cause.

Continued...

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