$1.9B in charges to medical device industry included in upcoming 5-year FDA agreement

The FDA and the medical device industry reached an agreement on key points of the fifth iteration of the Medical Device User Fee Amendments, Politico reported March 11.

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The five-year deal governs user fees the industry pays the FDA to fund product reviews. Revenue including those fees is expected to total $1.9 billion, the report said, about double the current version’s amount.

The current agreement is set to expire in September.

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