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Sen. Elizabeth Warren (D-Mass.) and two Senate colleagues are calling into question the statutory basis of a Food and Drug Administration software precertification program aimed at fast-tracking digital health products to market.October 31
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The Food and Drug Administration is moving toward requiring more electronic submissions of safety reports for products being evaluated by the agency.October 30
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The Food and Drug Administration has issued revised draft guidance on the categories of clinical decision support software subject to FDA oversight.October 1
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The Food and Drug Administration has plans to make the database that houses medical device reports submitted to the agency more user friendly.June 24
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The American Medical Informatics Association wants the Food and Drug Administration to improve its conceptual approach to regulating medical devices that leverage self-updating artificial intelligence algorithms.June 11
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Agency is looking for volunteers planning to submit a De Novo Request or 510(k) submission to evaluate Pre-Cert working model.May 28
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Agency reports that unauthorized system resulted in an insulin overdose requiring medical intervention.May 20
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The Food and Drug Administration is proposing recommendations on how to better design studies to assess pregnancy outcomes in women exposed to FDA-regulated drugs and biological products.May 13
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A Mount Sinai Health System startup, seeking to commercialize an artificial intelligence-enabled clinical diagnostic for kidney disease, has been granted priority regulatory review by the Food and Drug Administration.May 3
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The Food and Drug Administration issued a warning on Wednesday that medical devices marketed for the diagnosis of a head injury that have not been reviewed by the agency might not be safe or effective.April 11
