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Guidance Documents/Guidance-Document/Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling: Guidance for Industry and Food and Drug Administration Staff

Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling: Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

September 29, 2023

September 28, 2023

Center for Devices and Radiological Health

75f8c8db-da73-47f6-af44-69ed63ea0312

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