FDA’s Shuren Grilled About Handling Of MDUFA V At House Hearing

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.” 

CDRH director Jeff Shuren testifies in the US House of Representatives on 30 March 2022.
CDRH director Jeff Shuren testifies before the US House of Representatives health subcommittee on 30 March. • Source: YouTube/Informa

When the head of the US Food and Drug Administration’s device center came to Capitol Hill on 30 March to discuss the renegotiated user-fee agreement between the FDA and industry, the usual questions about agency policies and priorities were laced with frustration about the FDA’s management of the process.

“By statute, as part of the MDUFA reauthorization, FDA is mandated to consult with regulated industry, patient and consumer representatives, and health care professionals, receive public comment, and submit recommendations...

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