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.
A bevy of device- and diagnostic-related bills has bloomed this spring in the context of a GOP-led US Congress and White House and US FDA user-fee reauthorization activity.
On the regulatory front, the legislative efforts address everything from revamping oversight of lab tests to streamlining device facility inspections to setting up rules for over-the-counter hearing aids and third-party device services