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

Executive Summary

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.

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