The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation.
There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn.
Product dimensions: 6.00 (w) x 9.10 (h) x 1.20 (d)
Meet the Author
Carl T. DeMarco is an Adjunct Professor in the Engineering School at the Catholic University of America, where he teaches senior and graduate biomedical engineering students. After serving as a consultant to the U.S. Senate Office of Technology Assessment and serving in the Office of the Assistant Secretary of Health and the Office of Health Maintenance Organizations, DeMarco served many years in various management positions in FDA’s medical device program areas, including regulations policy, bioresearch monitoring, registration and listing, post-market surveillance, FOIA, guidance development, application integrity, and annual reporting. Prior to government service, he provided legal and legislative representation to industry and professional associations and served as the Director of the Health Law Center at Aspen Systems Corporation. DeMarco is also a principle author of District of Columbia Administrative Practice Manual (Lerner Law Book Co., Inc., 1969) and Pharmacy and the Law, Second Edition (Aspen Systems Corporation, 1984) as well as the author of many articles and chapters in other books and journals. He holds a B.S degree in pharmacy from Rutgers Pharmacy School and a Doctor of law degree from Rutgers Law Center and did graduate course work at American University’s business school in managerial statistics and computer applications for managers. DeMarco served on numerous government committees, panels, and boards. He has been a member of the American Bar Association (Food and Drug Committee and Committee on Exempt Organizations), District of Columbia Bar Association (Medico-Legal Committee), American Society of Hospital Attorneys, American Society of Hospital Pharmacists (served as General Counsel), Federal Bar Association (Health and Welfare Committee), American Health Lawyers Association, and American Society for Pharmacy Law (serving as president from 1977-1979).