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

 
• By Sue Darcey

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.

The House Energy and Commerce Health Subcommittee wants to attach four pieces of medical technology legislation to a must-pass user fee reauthorization bill. The bills seem non-controversial, but have some opponents, as a May 2 Health subpanel hearing revealed. (Also see "Bill Bonanza: US Congress Sprouts Medtech Legislation This Spring" - Medtech Insight, 2 May, 2017.) Full Committee Chairman Greg Walden, D-Ore., who sat in for a portion of the subcommittee meeting, said the bills will likely be linked to the MDUFA IV bill, and reflect "other member priorities that could strengthen the [user fee] legislation."

The bills in question cover:

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