New Details Emerge on MDUFA IV Reauthorization Commitments

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 were roughly 124 days and PMAs were 385 days.

Industry pressed the FDA not to include withdrawn de novo submissions in the new goal of 70 percent completion within 150 days by fiscal year 2022. However, the new goal does include withdrawn submissions because the FDA said its workload estimates included withdrawn submissions, so removing them would change the amount of effort required to meet the goals.

The FDA released minutes from its Aug. 15 final negotiation meeting where the two sides agreed on a draft commitment that will be delivered to Congress in January 2017. The agreement covers the terms for a new medical device reauthorization package that would allow the agency to collect $999.5 million in user fees over the next five years (IDDM, Aug. 29).

The FDA will also improve the CLIA waiver application process by establishing a centralized program management group within the Office of In Vitro Diagnostics and Radiological Health. It will offer more opportunities for interaction and will complete 90 percent of stand-alone CLIA waiver applications that don’t have a panel meeting in 150 days, 90 percent of dual 510(k) and CLIA waiver applications in 180 days, and 90 percent of stand-alone CLIA waiver applications that have a panel meeting in 320 days.

In comparison, the MDUFA III goal was 95 percent completion of stand-alone CLIA waivers that don’t have a panel meeting in 180 days, 90 percent of dual waiver applications in 210 days, and 95 percent of stand-alone applications that have a panel meeting in 330 days.

Independent Assessment

The two sides also agreed on an independent assessment of the medical device review process at CDRH, including an evaluation of FDA’s implementation of the corrective action plan developed in response to recommendations from the MDUFA III independent assessment. The scope of the assessment cannot exceed more than $6 million.

According to the meeting minutes, there was a fair bit of disagreement over the FDA’s request for $41.7 million for incentive pay to prevent attrition to other Centers should Congress agree to increase federal pay levels. FDA explained that the funds would allow it to increase pay for scientific, technical or professional positions that support the development and review of medical devices.

However, industry did not agree with those assertions, and said it would only allocate $7.5 million in user fee funding to improve retention. Industry did agree that if Congress does enact legislation to raise federal pay levels, it would work with the FDA to establish a plan that would address CDRH personnel issues to retain talented staff.

FDA workload issued were another area of concern for the agency, and one in which it was difficult to reach agreement. The FDA said there needed to be capacity planning to manage the device program, and it believed a workload adjustment mechanism that ties revenue to aggregate workload would be the best way to go.

But industry was concerned with fee predictability under the FDA’s proposal, and it made a counter-proposal to seek authorization to use over-collections and eliminate the fifth-year offset. The FDA eventually agreed to this proposal, but it was adjusted to indicate the number of pre-submissions subject to the goal rather than a percentage of all receipts.

FDA also committed to strengthening the third-party premarket review program by offering training to third-party review entities, conducting audits, publishing performance reports of individual third-party entities and seeking authority to expand the scope of the program with the goal of eliminating routine re-review by the FDA of third-party reviews.

Read the FDA meeting minutes here: www.fdanews.com/08-31-16-Meetingminutes.pdf.— Tamra Sami