RAPS

FDA updates medical device biocompatibility guidance with exclusion list

The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility issues medical device sponsors should consider in their premarket submissions. This is the second time the agency ...
MD&M East

Cytotoxicity Testing for Medical Devices: A Guide to Compliance & Best Practices

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, ...

Medical Device Testing Services Market Size to Reach USD 22.99 Billion by 2035, Growing at a 9.55% CAGR | SNS Insider

U.S. Medical Device Testing Services Market to Reach USD 7.05 Billion by 2035 at a 10.16% CAGR, While Europe Benefits from ...
RAPS

FDA publishes new dataset to aid medical device biocompatibility testing

The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that may not be biocompatible for use in ...