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Bill Bonanza: US Congress Sprouts Medtech Legislation This Spring

Executive Summary

A bumper-crop of bipartisan-sponsored, mostly industry-supported legislation seeking to streamline compliance, improve access or otherwise reduce burdens in the medical device space has surfaced in recent months under the GOP-led Congress, just in time to potentially be considered in conjunction with "must-pass" user-fee reauthorization. The bills' targets range from hearing aids to diagnostics and from facility inspections to device repair services to Medicare reimbursement. Here's a roundup of introduced and draft legislation compiled by Medtech Insight.

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House Subcommittee OK's FDA User Fee Bill; More Debate On Third-Party Servicers To Come

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.

User-Fee Facts: 10 Key Medtech Details From US FDA Agreements

While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.

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