FDA Draft Guidance Development Tools Qualification

FDA’s Device Center issued a draft guidance “Medical Device Development Tool”. The direct link is provided. NOTE that this guidance is not for development tools in general. It defines a qualification and FDA submission and determination process for specific types of tools related to clinical and nonclinical evaluation. It provides a mechansim for FDA to essential approve a tool for specific intended use in device evaluation with the intent of streamlining the review process for devices whose performance device was based on tools that were pre-qualified with FDA.

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