Sign at the Food and Drug Administrations campus in Silver Spring, MD. Courtesy FDA Government regulation is supposed to make products safer. But new research shows that, at least for medical devices, ...
Once a medical device is brought to market, FDA surveillance of its safety continues. “To facilitate incremental improvements in safety and effectiveness, the FDA allows manufacturers to modify ...
The U.S. Food and Drug Administration has issued a proposed rule to reclassify surgical mesh for transvaginal repair of pelvic organ prolapse as a Class III “high-risk device.” The mesh is currently ...
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...