MEDIcept Insights

FDA Recognizes NEW Key Cybersecurity Standard

FDA Recognizes NEW Key Cybersecurity Standard

Introduction  On November 7, 2023, FDA formally recognized a new cybersecurity standard titled ANSI AAMI SW96:2023 Standard for medical device security – Security risk management for device manufacturers [1]. This announcement comes after the standard was added to...

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Laboratory Developed Tests – FDA's New Proposal

Laboratory Developed Tests – FDA's New Proposal

Introduction  On September 29th, FDA announced a proposed rule regarding Laboratory Developed Tests (LDTs). LDTs are IVDs that are designed, developed, and used within a single laboratory. This new rule aims to improve the safety and effectiveness of these tests by...

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FDA’s New Breakpoints in Device Labeling

FDA’s New Breakpoints in Device Labeling

Introduction to the Guidance  FDA issued a new guidance document “Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling”. The purpose of this guidance document, issued on September 29, 2023, is to inform industry of the...

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