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 ...

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 ...