MEDIcept Insights

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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Is Your Product a Medical Device or a Borderline Product?

Is Your Product a Medical Device or a Borderline Product?

The demand for medical devices in the UK has soared, prompting manufacturers to navigate complex classifications. While global acceptance is a factor, it doesn’t always align with the standards set by the MHRA. To ensure compliance, manufacturers must decode the UK’s...

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