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FDA Policy on When Software that Uses Artificial Intelligence and Machine Learning qualifies as a Medical Device

As more artificial intelligence products become available, the FDA is reevaluating its approval criteria. For now, De novo approval and 501(k) are being used along with premarket approval.

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Does FDA Deem My Product to be a Medical Device?

Does FDA deem your product to be a medical device, or is it just a consumer product that would not be regulated by FDA? Here are basic steps you can take to work through the puzzle.

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How to choose a healthcare lawyer or FDA attorney and regulatory consultant

The best way to select a healthcare lawyer or FDA attorney (or FDA regulatory consultant) for legal advice about your health and wellness service, practice, facility, or product, is to follow [...]