Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This ...

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 ...

The FDA has proposed to reclassify surgical staplers as higher-risk medical devices—therefore requiring premarket reviews, agency clearance and performance studies—following an increasing number of ...

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 ...

What do a thermometer, an artificial heart and an at-home pregnancy test kit have in common? They are all "medical devices," and they have all traveled the same road, from idea to marketable product, ...