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15Order Now! Call Toll-Free (800) 260-4754Medical Devices Lawand RegulationAnswer Book 2013Edited by Suzan Onel (K&L Gates LLP) andKaren M. Becker, Ph.D. (IndigoBay Ventures LLC)The regulation of medical devices has grown increasingly complex since the Medical DeviceAmendments to the federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976.Medical Devices Law and Regulation Answer Book 2013 walks you through the currentregulatory requirements and describes every aspect from premarket requirements for specifictypes of devices, to postmarket regulation and ongoing government enforcement and investigation.With over thirty contributors from a variety of major law firms and consulting firms specializing inmedical device work, Medical Devices Law and Regulation Answer Book 2013 provides practicalguidance on how to handle everyday questions on a wide variety of topics, as well as what issuesare likely to arise and how to avoid them.1 softcover volume, 1,014 pages, $235, Order #38094100% Satisfaction Guarantee!If you’re not satisfied with your purchase for any reason,simply return it within 30 days for a full refund.