Foreword, Bert Spilker. Part I. Fundamentals of Clinical Study Design and Evaluation. Clinical Trials in Development and Marketing of Medical Devices, Karen Becker Witkin. Observational Research: The Nonexperimental Approach, Rosanne B. McTyre and Linda M. Pottern. Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devices, Selma A. Kunitz, Michele Gargano, and Rene Kozloff. Regulatory Requirements for Clinical Trials of Medical Devices and Diagnostics, Sharon A. Segal. Part II. Introduction to Case Studies, Karen Becker Witkin. Clinical Studies of Prosthetic Heart Valves Using Historical Controls, Gary L. Grunkemeier. Prospective Multicenter Clinical Trials in Orthopedics: Special Concerns and Challenges, John D. van Vleet. Long-Term Evaluation of Total Hip Arthroplasty, Frederick J. Dorey. Injectable Collagen and a Rare Adverse Event-True Association or Artifact?: Results of Postmarket Surveillance Research, Diane E. Mandell, Rosanne B. McTyre, Frank DeLustro, and Ross Erickson. In Vitro Diagnostics: Design of Clinical Studies to Validate Effectiveness, Wayne R. Patterson. A Controlled Study of Intra-Articular Hyalgan® in the Treatment of Osteoarthritis of the Knee, Roberto Fiorentini, Frank C. Dorsey, Sharon A. Segal, and Roland Moskowitz. Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves, Frederick J. Schoen. Polyurethane Pacemaker Leads: The Contribution of Clinical Experience to the Elucidation of Failure Modes and Biodegradation Mechanisms, Ken Stokes. Glossary. Index.