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

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.

The investigation focused on the 510 (k) devices that had been subject to a Class I recall between 2017 and 2021. That group spanned 156 products, approximately 28% of which had faced at least one ...

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 ...

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.

Forty-three years later, the Food and Drug Administration and a medical device company fell into a misunderstanding about a product’s regulatory classification and status.

FDA's drug delivery device recall spree continues with Class I tag for B. Braun infusion pump By Andrea Park Nov 20, 2023 10:45am B. Braun Class I recall infusion pump FDA ...