Senate HELP Committee Passes User Fee Package

US FDA user fees took another step toward renewal Tuesday as the Senate’s Committee on Health, Education, Labor and Pensions (HELP) voted to support the bill along with other health-related issues.

A United States Senate committee hearing room in Washington, DC.
• Source: Shutterstock

It was a long road for the Medical Device User Fee Amendments, also known as MDUFA V, this time around. Thanks to pandemic-related delays, the US Food and Drug Administration and medtech industry didn’t even start their negotiations until about a year after what was originally planned. And then talks dragged on as the sides bickered. By the time a draft commitment letter made it to Congress, the statutory deadline was two months past.

But things have been moving a lot more smoothly since lawmakers took up user fee legislation. The House of Representatives...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By 

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.

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.

Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.

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.