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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