US Capitol FDA Approval Process

Pending the expected signature of President Trump, MDUFA IV will be implemented (along with PDUFA VI and GDUFA II). Passage, including the associated rise in user fees for device manufacturers over the term of the act (FY18-22), was largely expected.

Legislative politics involve give-and-take, of course, and increased user fees are reasonably expected to result in systemic improvements in regulation, via industry favored initiatives. FDA has described their “give” portion of the give-and-take process in the document MDUFA Performance Goals and Procedures, Fiscal Years 2018 Through 2022. Unsurprisingly, focus remains on Total Time to Decision metrics for premarket submissions. The linked MDUFA Performance Goals document describes some of the approval or clearance process mechanisms by which improvements in Total Time to Decision might be achieved, as well as various cooperative review mechanisms planned. The Pre-Sub program will be continued, with specific requirements on response timing and meeting date options, and required publication of an updated version of the Request for Feedback on Pre-Market Submissions guidance document. Another provision of the bill requires annual reporting on the previous year’s inspection activities for device and drug facilities, including timing information. Those who have been subjected to lengthy or highly intermittent inspections, or delays in comment on response adequacy, are likely to welcome this additional scrutiny of inspection timelines.

There were several amendments to the act. One of those modifies section 513 of the FD&C act to require risk-based classification of device accessories (as opposed to classifying accessories at level of the classified device they are supporting). Another requires FDA to submit a report to house and senate committees articulating a strategy for regulation of device “servicing” activities within 180 days of passage.

Passage will allow continuation of other FDA internal projects including continuing development of the agency Quality Management System, additional training for reviewers, access to independent experts to facilitate reviews, the Digital Health Initiative, the Real-World Data Initiative, TPLC expansion, Accreditation Scheme for Conformity Assessment (ASCA) for Test Laboratories, and many others.

In an age of budget uncertainty and resource restraints, passage of the bill provides some level of resource assurance for the agency, while increasing visibility of key stakeholder issues.

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