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Guidance Documents/Guidance-Document/Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

July 31, 2025

July 30, 2025

Center for Devices and Radiological Health

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