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Home » MDUFA IV Would Raise Fees, Reduce Time for Decisions
MDUFA IV Would Raise Fees, Reduce Time for Decisions
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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
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