Senate, House Panels Release Clean Device User-Fee Discussion Draft
Lawmakers emphasized the need for a swift reauthorization of a combined US FDA device and drug user-fee reauthorization bill before the end of July, and released a clean discussion draft April 14 that mirrors the agreements reached by industry and the agency last summer.
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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.
Sen. Amy Klobuchar, D-Minn., is putting together a coalition of lawmakers who favor repeal of both the medical device excise tax and the Affordable Care Act's so-called "Cadillac tax" on high-expense health-care plans.
The clinical lab industry and IVD test-kit-makers appear ready to work with lawmakers on diagnostic reforms that would create a new category of regulated product for all lab tests that would undergo a mix of US FDA and CMS oversight. Meanwhile, key groups representing laboratory professionals remain fundamentally opposed to the concept.