1. Medtech Insight

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

(MMD Creative/Shutterstock)

With just over two years left in the current medical device user fee agreement, prep work on the next version is kicking into gear. The US Food and Drug Administration has taken the first official step by announcing plans for a public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal 2028 through 2032 (MDUFA VI).

The five-hour event will be held on 4 August at the FDA’s White Oak campus. Registration...

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