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dec 8, 2017 - SaMD Clinical Evaluation Draft Guidance

Description:

The draft guidance pertains to the conduct of clinical evaluation of Software as a Medical Device (SaMD) and focuses on the general principles of clinical evaluation, which includes establishing the scientific validity, clinical performance, and analytical validity for a SaMD. This draft guidance is not final nor is it in effect at this time.

Added to timeline:

8 months ago
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SAMD Timeline

Date:

dec 8, 2017
Now
~ 11 months ago
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