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FDA Pre-Cert

The FDA has released an updated model of its software pre-certification pilot to help guide streamline the approval process for companies develop digital health solutions. more

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The FDA is considering changes to the way it regulates pathways for software used as a medical device (SaMD), according to law firm, Dentons. more

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In response to the increasing adoption of wellness apps and health technologies, the FDA has released new guidance for the development of digital health tools. more

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