MDUFA IV Would Raise Fees, Reduce Time for Decisions

Two months after industry and the FDA approved an agreement on the MDUFA IV reauthorization, the agency on Oct. 25 released the document, under which it would use a $320 million increase in user fees to implement a host of process improvements sought by device manufacturers.

The FDA has agreed to cut time-to-decision goals for 510(k)s from 124 to 108 days, provide meaningful written feedback to companies at least five days before a scheduled pre-submission meeting and update its guidance on the pre-submission process as part of its efforts.

In addition, for the first time, the FDA would be required to document the scientific rationale for issuing a deficiency letter to a sponsor. — Jeff Kinney