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

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 ...

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 ...

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 ...

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.

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.