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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 might attract any controversy to the must-pass bills could risk...

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