We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
In yet another move toward precision medicine this week, the FDA is mapping out co-development pathways for companion diagnostic devices to accompany targeted therapies. Read More
FDA is recommending that device manufacturers redesign heater-cooler devices used in surgeries because cleaning maintenance challenges have been linked to infections and patient deaths. Read More
FDA is incorporating a risk-based approach for analyzing biocompatibility of medical devices that come into direct or indirect contact with the body. Read More
The FDA will now allow certain devices to carry stand-alone symbols on labels, in an effort to harmonize international standards used in medical device labeling. Read More
If the FDA conducts a benefit-risk assessment and finds the device has a high benefit to patients and the compliance issue causes little risk, it may decide to work with a company informally, rather than taking an official enforcement action. Read More