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.

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 ...

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 ...

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

However, FDA will maintain its enforcement date for compliance with UDI labeling, date format, and direct-mark requirements for Class I and unclassified devices on September 24, 2022 as previously ...

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.

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.

We need FDA to develop a master plan for the classification of health information technology (HIT) type medical devices. This master plan could lay out the landscape of HIT- type medical devices, give ...

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 ...

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.