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dec 8, 2017 - Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act

Description:

A draft guidance that provides clarity on FDA’s current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the resulting effect on guidances related to medical device software. This draft guidance is not final nor is it in effect at this time.

Added to timeline:

8 months ago
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Date:

dec 8, 2017
Now
~ 11 months ago
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