The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into ...

The Food and Drug Administration has finalized guidance on manufacturers notifying the agency of changes that could likely disrupt the supply of medical devices. Officials created the guidance to ...

The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...

The FDA today issued an alert around a safety concern regarding diabetes devices that rely on smartphones to deliver critical ...

The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...

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The commercial manufacturing example involves an AI-based visual analysis ... FDA explains what documentation and information should be included in marketing submissions for devices with AI ...

The GAO report determined the FDA did not meet its foreign inspection targets between fiscal year 2018 and fiscal year 2023. “According to our analysis of FDA data, the number of foreign ...

A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's accelerated approval process, and is using treatments from Sarepta Therapeutics ...

Jacobs is chief transformation officer of the Center for Medicare. Tarver is director of the FDA’s Center for Devices and Radiological Health. McMullen is director of the FDA’s Office of ...

The OIG report points out that for both eteplirsen and aducanumab, FDA evaluated analyses were not included in the sponsors' original analysis plans. Also, concerns about the efficacy of both ...