Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...

FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...

The majority of cardiovascular devices with Class I recalls from the US Food and Drug Administration made it to market without appropriately rigorous premarket clinical testing, a new analysis has ...

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...