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

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its asse

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions i

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