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Risks Of Missing Reauthorization Deadline Highlighted At User-Fee Hearing

Executive Summary

FDA center directors, including device chief Jeffrey Shuren, told lawmakers they are committed to reauthorizing user-fee programs during a March 21 Senate hearing. The officials wouldn't comment on a recent budget proposal from the Trump administration that seeks more user fees and less appropriations from Congress that industry agreed to.

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Gottlieb Wants Timely Approval Of User Fee Bill, Balanced LDT Plan

FDA Commissioner-nominee Scott Gottlieb was approved by the Senate HELP committee April 27, sending his confirmation to the full Senate. Written responses from Gottlieb to senators' questions provided in advance of the vote don't hold any big surprises, but they provide a view into priorities of the incoming official and the lawmakers, including quick user-fee reauthorization, resolving the lab-developed test oversight debate, off-label and "right-to-try" issues and post-market surveillance.

Legislation Would Streamline Risk-Classification For Device Accessories

A bill introduced in the US that industry stakeholders want to be added to the "must-pass" user-fee reauthorization bill would create a tailored approach to classifying or reclassifying device accessories, following up on change made last year that requires accessories to be classified separately from parent devices. Streamlining accessory oversight has been an industry goal, particularly of health-software makers.

Senate, House Panels Release Clean Device User-Fee Discussion Draft

Lawmakers emphasized the need for a swift reauthorization of a combined US FDA device and drug user-fee reauthorization bill before the end of July, and released a clean discussion draft April 14 that mirrors the agreements reached by industry and the agency last summer.

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