When I was writing last month’s column about former CDRH engineer Leroy Hamilton’s down-the-rabbit-hole quest for a better Form FDA-3429 for guiding device classifications at CDRH, I had no way of ...

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 ...

BETHLEHEM, Pa., Dec. 5, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading provider of private-label orthopedic and spinal implants, proudly announces that it has received Medical Device Regulation ...

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 ...