FDA Returns To MDUFA Table With High, Low Proposals

The priorities-gap between FDA and industry in MDUFA IV negotiations is narrowing. In May, the agency returned with counter-proposals that reduce user-fee increases compared to its prior plans, though there is still at least a $160m difference from the most recent proposal that is public from industry.

The most recent Medical Device User Fee Act negotiation meeting minutes posted by FDA suggest that regulators and industry are getting closer to agreeing on components of a MDUFA IV proposal. Returning to the negotiating table on May 16, the agency presented two proposals to industry that are approximately $30m apart.

During the meeting last month, FDA presented a proposal that that would raise $680 million plus inflation through device user...

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 Legal & IP

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By 

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By 

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By 

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

More from Policy & Regulation

From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

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.