FDA Seeks Input On Health Impact Of Non-Device Software Functions

By Jessica Karins / July 8, 2024 at 5:20 PM
FDA is asking stakeholders for comments on how non-device software functions related to health care impact patient safety, a request that comes as a major medical device industry group calls on the agency to narrow its oversight of clinical decision support software, saying FDA’s interpretation of when it constitutes a device is overly broad. In a June 18 request for input , FDA seeks feedback on best practices for promoting patient safety in relation to medical software functions that, under...

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