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Will Senate User-Fee Package Be Smooth Sailing Despite Add-Ons?

 
• By Sue Darcey

The Senate HELP Committee is ready to mark up user-fee reauthorization legislation May 10 that includes several device add-ons to the core industry-FDA agreement. Most of the additional reforms are supported by industry, but staffers have warned that putting too much extra legislative baggage into the user-fee package could slow it down. Reforms included address device facility inspections, device accessories' classification and post-market surveillance, among other issues.

The Senate Health, Education, Labor, and Pensions (HELP) Committee plans to mark up a user-fee reauthorization "manager's amendment" May 10 that adds on reforms addressing device facility inspections, device accessory classification, over-the-counter hearing aids and medtech post-market surveillance pilot projects, among others.

Most of the added reforms are supported by industry, but congressional health policy staffers have warned that adding measures that...

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