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Home » FDA’s artificial intelligence paper prompts concerns regarding practicability
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FDA’s artificial intelligence paper prompts concerns regarding practicability

July 6, 2020
By Mark McCarty
The comment period has closed on the U.S. FDA’s discussion draft for artificial intelligence (AI) in medical devices, a paper that attracted the attention of medical societies and regulated industry. One of the questions posed by industry was whether the FDA is in a position to deal with the massive volumes of data developers would have to disclose to the agency, creating concern that such disclosures would amount to little more than an obligatory and useless data dump.
BioWorld MedTech Regulatory Artificial intelligence Digital health SAMD FDA

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