US FDA Proposes Independent Contractor To Track User Fee Dollars Used To Pay FTEs
The agency published minutes from three MDUFA V user fee meetings with medtech industry. The talks include conversations about carryover funds and filling FTEs from past user fee deals.
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Jeff Shuren, the director of the US agency’s device center, was quizzed by the House health subcommittee on why the new user-fee deal had reached Congress late and why there was an apparent lack of transparency around the negotiation process, among other issues. Shuren said part of the delay was due to the center and industry being “hammered by COVID.”
The US agency and the medtech industry still have significant disagreements, which means they will miss a 15 January deadline to send the MDUFA V user-fee deal to Congress. Insiders disagree, however, on how severe those disagreements are and when a deal can be reached.
A case study of the Penumbra JET 7 class I recall in JAMA has again raised concerns about shortcomings in the US FDA’s 510(k) pathway in the medical community.