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House Committee Advances User Fees With Full Slate Of Device Amendments

 
• By Sue Darcey

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.

Capitol House

[Editors' note: Follow progress with legislation impacting the device and diagnostics industry with the Medtech Insight's US Congress Tracker.]

The House Energy and Commerce Committee approved the House FDA Reauthorization Act (FDARA), which includes the FDA-industry MDUFA...

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• By Eileen Francis

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The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

More from Policy & Regulation

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By Elizabeth Orr

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.

Injuries And Deaths Linked To Baxter Infusion Pump

 
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The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Bates To Energize UK Office For Life Sciences

 
• By Ashley Yeo

Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.