The FDA will now be able to make the classifications based on the Asean Medical Device Directives, which classifies a device from A to D, depending on the risk it poses to the patients.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

These devices have simpler designs than Class II and Class III devices. 5 About 47% of medical devices fall under this category, and 95% of them are exempt from the FDA’s regulatory process.

The FDA noted in December 2021 that it intends to publish a Federal Register notice with a preliminary list of combination devices currently classified as drugs that are likely to be reclassified ...

The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula ...

FDA medical device recalls often allow products to stay on the market, leading to adverse events and patient deaths. ... From 2019 to 2023, there were 338 Class I medical device recalls, ...

Today there’s thousands upon thousands of medical devices registered to the FDA. But in 2022 the number of recalled devices were the highest in the past two years, according to an industry ...