Zdrowie i gospodarka · 17/01/2014

FDA Issues Final Order for Transilluminator and SHS Devices for Hepatic Coma and Poisoning Treatment

The FDA is requiring the submission of premarket approval applications for transilluminator devices used in breast evaluation and SHS systems for treating hepatic coma and metabolic disturbances, while reclassifying SHS devices for treating poisoning and drug overdose from Class III to Class II with special controls.