1. Medtech Insight

MDUFA IV Fees Unveiled: Changes For 510(k)s, Small Business, De Novos

Prior to a Nov. 2 public meeting on the tentative MDUFA IV deal between FDA and industry, the agency released its proposed commitment letter and new details on the structure of user fees in the deal, including an increased 510(k) rate, more protection for small businesses and a new fee for de novo submissions.

MT1610_StackedCoinsFEES_1200x675

A week before CDRH is set to hold a public meeting to discuss the latest medical device user-fee proposal, the agency released full details of the tentative MDUFA IV deal struck with industry in August, including the planned structure of user-fee payments from fiscal years 2018 to 2022 and the FDA commitment letter.

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

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.