Medical Devices

FDA Seeks Comment on Class 1 Accessories

The U.S. Food and Drug Administration (FDA) is seeking public comment on a proposed list of medical device accessory products that it believes are suitable for Class I classification. According to a Notifica... Read More...

FDA Updates List of Recognized Standards

The FDA has published an updated list of recognized consensus standards that can used in support of premarket medical device reviews conducted by the agency.

EpiPens Recalled Due to Defective Part

Meridian Medical Technologies, the manufacturer of Mylan’s EpiPen-brand of epinephrine auto-injectors, has announced a voluntary recall of selected EpiPen lots due to safety concerns. According to the compan... Read More...