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Small Business Final Guidance Medical Devices

Hogan Lovells

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

Hogan Lovells on

On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous guidance document dated...more

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