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House To Link Inspections, 3rd-Party Servicer, OTC Hearing Aid Bills To User-Fee Train

Executive Summary

A House Health subcommittee wants to attach a quartet of medtech bills to a fast-moving user fee package in Congress. The bills, which got a hearing before the Energy and Commerce Committee Health Subcommittee May 2, would streamline inspections and third-party certifications of device exports, refine FDA regulations on over-the-counter hearing aids, make third-party device equipment servicers register and file complaints with the agency, and clarify FDA product-center jurisdiction for contract agency-dependent imaging equipment.

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