FDA, Industry Getting Closer to MDUFA Agreements
The FDA’s recent MDUFA counter-proposal suggests a slowly closing gap between the agency and industry negotiations.
Updated meeting minutes from May 16, present the agency’s counter-proposal, which presented two options with different levels of performance targets and associated resources needs, with an estimated $30 million difference between the two options.
The agency is seeking roughly $160 million more than industry’s proposal from the last meeting. Under the lower option, the FDA is asking for $291 million over five years to add 186 full-time employees. On the higher option, the agency is asking for $321.7 million to add 215 FTEs by the end of MDUFA IV.
The counter-proposal includes a reduced FTE hiring plan, with adjusted counts aligned with the agency’s low and high proposal options. The FTE’s are reserved for pre-submissions, MDUFA quality management framework, supervisors, de novo programs and expanding overall reviewer capacity.
The FDA said the lower option should result in a reduction of average decision time to 120 days for 510(k)s and 300 days for PMAs by the end of 2022. The high option proposal should result in a reduction of average decision time to 119 days for 510(k)s and 290 days for PMAs.
Components of the two options could be reorganized to create a hybrid counterproposal, the agency said, noting that its most current counter-proposal requests fewer resources than its previous proposal.
No changes were made to the FDA’s proposal on quality metrics, independent assessment and myDevices portal. The agency reduced the cost of its proposal package by removing a plan to establish an “integrated review” process model for the Office of Device Evaluation.
Although gaps remain, both parties are moving closer to agreeing on a proposal package.
In a comparison between FDA’s most recent proposal and industry’s proposal from April 27:
- Industry and FDA see eye-to-eye on: quality management systems, device submission and review IT portals, independent assessment and standards programs; and
- A gap remains in: third-party 510(k) review programs, recruitment, digital health, pre-submission program, de novos, user-fee adjustment mechanisms, real-world evidence, patient engagement, management capacity and incentives, CLIA waiver reviews and shared-decision goals.