Bill Bonanza: US Congress Sprouts Medtech Legislation This Spring

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.

Capitol House

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...

More from Legislation

House Bill Calls For ‘Non-Flushable’ Label On Personal Wipes

 

The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

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

 

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

Injuries And Deaths Linked To Baxter Infusion Pump

 

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 

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.

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By 

The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.