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Shuren Defends Tentative User Fee Agreement On The Hill

Commonly paid user fees, such as the small business 510(k) submission fee, would not increase as dramatically as an overall doubling of total device user fees would suggest, argued the CDRH director, in defending a tentative FDA-industry agreement at a House hearing.

CDRH Director Jeffrey Shuren defended an agreement with industry to double device user fees over five years, in speaking to lawmakers last week, and argued that not all fees paid by individual companies would increase by a substantial amount.

The House Energy & Commerce Health Subcommittee held its first hearing on device user fee reauthorization Feb. 15, even though FDA and industry have yet to send a proposal to Congress. But the two sides have announced an agreement “in principle” in which FDA would collect $595 million from fiscal 2013 to fiscal 2017 in return for new performance goals and other commitments intended to ensure faster, more predictable pre-market reviews

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