FDA lays out cross-agency ef­forts on reg­u­lat­ing AI in med­ical prod­ucts

The FDA is spelling out its game plan for reg­u­lat­ing ar­ti­fi­cial in­tel­li­gence in med­ical prod­ucts, ac­cord­ing to a pa­per pub­lished Fri­day.

The sev­en-page re­port was a joint ef­fort be­tween the FDA’s bi­o­log­ics, drug, and de­vice cen­ters and the Of­fice of Clin­i­cal Phar­ma­col­o­gy to high­light cross-agency col­lab­o­ra­tion on AI. The pa­per comes amid a tight­ened fo­cus on AI in re­cent years as it be­comes more wide­ly used in med­ical prod­ucts.

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