From 2019 to 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 were removals, FDA spokesperson Amanda Hils told CBS.

Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is ...

An overview of the legal framework and policies for marketing and advertising drugs and medical devices (medical products) regulated by the US Food and Drug Administration (FDA).

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 ...

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 ...

A new JAMA study says FDA medical device authorizations may not be safe for patients. The loophole is part of something called the 510(K) pathway.

Vestagen Protective Technologies, a developer of healthcare worker uniforms and scrubs, received FDA clearance as a Class II medical device for its Vestex apparel — the first daily-wear scrubs ...

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 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.