The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976.  Medical Devices Law and Regulation Answer Book 2011-12 walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation.

With over 30 contributors from a variety of major law firms and consulting firms specializing in medical device work, Medical Devices Law and Regulation Answer Book 2011-12 provides practical guidance on how to handle every day questions on a wide variety of topics as well as what issues are likely to arise and how to avoid them. 

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