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Guidance Documents/Guidance-Document/Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff

Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

September 14, 2023

September 14, 2023

Center for Devices and Radiological Health

615429e8-d815-4bf4-bfc5-68955cba75bb

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