1. Medtech Insight
  2. >>Policy & Regulation

Trump Budget: 71% Of US FDA Device Funding Would Come From User Fees

 
• By Sue Darcey

The Trump White House is not backing down in its push to renegotiate the US FDA user-fee reauthorization deals that were inked during the Obama administration. The FY 2018 budget request would ask for more than a $200m increase in fees from device companies in the coming fiscal year to counterbalance major cuts in appropriations from Congress. That would make the agency's device program dependent on user fees for about 71% of its budget, versus about 27% currently. But Congress has already said it opposes the plan.

The Trump administration's FDA is sticking with its effort to renegotiate the MDUFA IV user-fee deal in its FY 2018 budget request, asking the device industry pay an additional $250m-plus in fees next fiscal year beyond what was agreed to.

But the administration push to "recalibrate" the user-fee programs at this stage has already been rejected out of hand by...

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
Start Free Trial

Already a subscriber?

More from Legislation

More from Policy & Regulation

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.