New Details Surface on MDUFA IV Reauthorization Commitments

September 8, 2016

New details have emerged on the MDUFA IV reauthorization negotiation between the FDA and the medical device industry that include an agreement that the agency will reduce the average decision time to 108 days for 510(k)s and to 290 days for PMAs by fiscal year 2022.

Under MDUFA III, 510(k) decisions took 124 days and PMAs took 385 days.

Industry pressed the FDA not to include withdrawn de novo submissions in measuring achievement of the new goal of 70 percent completion within 150 days by fiscal year 2022. The FDA said the new goal does include withdrawn submissions because the agency’s workload estimates included withdrawn submissions, so removing them would change the amount of effort required to meet the goals. — Tamra Sami

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