Following the Trump administration's DEI ban, the FDA's move to scrub webpages has ensnared many pages focused on ensuring ...

CHICAGO (Reuters) - The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...

Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new ...

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

To address these shortages, the FDA has put measures into place, including expedited review processes and the use of enforcement discretion. The FDA also now requires manufacturers to give at least ...

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...

The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...

Amid a deluge of executive actions, the Trump administration has directed federal health agencies to pause external ...

FDA Medical Device Regulation Over the Use of AI in Clinical Trials As FDA noted in the JAMA article, artificial intelligence and machine learning (AI/ML) have many potential uses in clinical ...

By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...