User Fee Reauthorizations Begin With Public Meeting on MDUFA V
The US Food and Drug Administration (FDA) on Thursday announced the first public meeting on 7 April to kick off the next round of Medical Device User Fee Amendments for fiscal years 2023 through 2027 (MDUFA V).The current user fee legislation (MDUFA IV) expires on 1 October 2022, and it spells out exactly how much device manufacturers must pay FDA for reviewing their various applications, and in turn, FDA has to meet certain goal dates for its reviews.
Prior to beginning further negotiations with industry on the user fee reauthorization, goal dates and prices, FDA is required by law to request public input on the reauthorization, hold a public meeting where different views can be presented, including suggestions for changes to goals, provide 30 days for written comments after the meeting and publish those comments on FDA’s website.
As far as what FDA is interested in hearing from stakeholders, the agency offered four questions:
“1. What programs/commitments under MDUFA IV are currently working well?
2. What programs/commitments can be improved for MDUFA V?
3. What new programs/commitments should be considered as part of MDUFA V?
4. Thinking more broadly than the MDUFA program alone, what should the medical device ecosystem, and our medical device program in particular, look like at the end of MDUFA V (i. e., September 2027), and how can MDUFA V support achieving that future state?”
The meeting will include a series of panels of different types of stakeholders, such as patient advocates, consumer protection groups, industry, health care professionals and academic researchers.
Individuals will be afforded time to offer their own presentations, but FDA says that these presentations “should focus on program improvements and funding issues, including specific suggestions for changes to performance goals, and not focus on other general policy issues.”
The agenda of the meeting will be made available by next Friday, 12 March.
Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027