This publication brings together all of the articles in MD&DI's groundbreaking series on clinical trials, an area of growing concern to device manufacturers. Articles in the series offer in-depth coverage of the critical information that device manufacturers must know in order to comply with FDA's expectations for clinical data and to establish a firm footing for the marketing of their products. Includes comprehensive discussions of relevant FDA regulations, clinical trial design, study logistics, data analysis, and FDA enforcement policy. The essential companion to FDA’s Investigational Device Exemptions Manual.