House To Link Inspections, 3rd-Party Servicer, OTC Hearing Aid Bills To User-Fee Train
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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US Congress successfully pushed through a user-fee bill in 2017 to help smooth the regulatory path at FDA for medical devices and other products, but other efforts, including several industry priorities, remain undone. On top on the list, of course, is the effort to repeal the device excise tax. But legislation is also on the table to address diagnostics regulation, telehealth reimbursement, and medtech cybersecurity vulnerability, among other issues. Here is a look at the medtech landscape in Congress in 2018.
House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.
The House Energy and Commerce Health Subcommittee passed a bill reauthorizing FDA's device user fees May 18, along with amendments on over-the-counter (OTC) hearing aids and to streamline agency inspections of device facilities, among others. The subpanel agreed to shelve – for now – a proposed bill to facilitate off-label communications by medical product firms, and said they will wait for the full committee markup to debate a third-party servicers bill backed by imaging firms.