- November 27, 2021
MDUFA IV, which provides for an inflation adjustment to be compounded for FY22 and each subsequent fiscal year, “specifies that the base fees of $329,000 (premarket application) and $4,978 (establishment registration) are to be adjusted for fiscal year 2022 using the same methodology as that for the total revenue inflation adjustment,” according to the Agency announcement.
Under MDUFA IV, the Medtech industry provides $999.5 million to FDA over five (5) years in additional financial resources and in return the Agency is held to performance goals meant to improve the efficiency, predictability and transparency of its review process. These process improvements include significantly improved total review times for PMA and 510(k) submissions.
AdvaMed had called MDUFA IV a “win-win-win” for patients, FDA, and innovation. However, the start of the reauthorization process or the fifth round of its medical device user fees program has exposed “fundamentally different” views in talks between FDA and device companies on the path forward.
Meeting minutes from a late April (2021) virtual event revealed disagreements over the FDA’s vision for its Total Product Life Cycle Advisory Program (TAP). Industry wants more predictable — and faster — premarket review times for medical device submissions and contends that TAP will add significantly to the complexity of the premarket review process, which has not been reliable as the FDA works through the disruption and heavy workload brought by the pandemic.
FDA continues to struggle in 2021 in balancing its Coronavirus-related regulatory workload and non-COVID-19 activities, according to Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH). Shuren said in May 2021 that it is possible this year (2021) that CDRH might miss some of the MDUFA performance goals to reduce the average total time to decision for PMA applications and 510(k) submissions.
However, CDRH should be back to normal by the end of 2021, with some remaining work and backlogs lingering into 2022, Shuren said in July 2021. “[The COVID-19 pandemic] put tremendous a strain on the system, and it has really shown the limitations in the system,” the Director commented. “There is not a lot of give.”
REFERENCE: Med Tech Dive; 02 AUG 2021; Greg Slabodkin