Christina Kuhn

Christina Kuhn provides pharmaceutical and medical device companies advice on a variety of federal and state regulatory matters.

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FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

By Christina Kuhn, Scott Danzis & Wade Ackerman on October 9, 2019

Posted in Artificial Intelligence (AI), Health Issues, Uncategorized

On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ensure

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Christina Kuhn

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

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