Starting September 24, the Food and Drug Administration will require all Class II devices to be labeled with unique device identifiers. The FDA introduced the unique device identifier system in 2013 ...

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 ...

On Oct 7, 2021, FDA issued a guidance on surgical staplers and staples for internal use, reclassifying them from Class I (general controls) to Class II (special controls) devices and requiring them to ...

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 ...