"Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compli

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. Thi

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 objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the

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