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BioWorld - Friday, March 27, 2026
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Home » Industry submits $1.65B counterproposal package for next device user fee schedule
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Industry submits $1.65B counterproposal package for next device user fee schedule

Oct. 27, 2021
By Mark McCarty
Negotiations between the FDA’s device center and the med-tech industry over the next device user fee schedule are dragging on, but the gap between the two sides may have narrowed. The FDA had previously proposed a package that ran more than double the current total user fee volume, and industry has responded with a proposal that would provide the agency with $1.65 billion in user fees over five years, leaving the two sides with a gap of more than $800 million to bridge.
Medical technology Regulatory U.S. FDA

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