Should We Regulate Direct-to-Consumer Health Apps?
Over 318,000 health apps are available in app stores, but only a fraction are regulated by the U.S. Food and Drug Administration.
software as a medical device
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Read more: A Closer Look at FDA’s Newly Released AI/ML Action Plan A Closer Look at FDA’s Newly Released AI/ML Action Plan
FDA’s new Action Plan takes steps toward establishing a dedicated regulatory strategy for AI products intended as software as a medical device.
