Book of Donmon Teith

The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were intr

The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health

On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety a

The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within bind