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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