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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.
16What’s Inside:1. Overview of the Legal Framework for MedicalDevice Regulation in the United States2. Clinical Studies of Investigational Devices3. Device Premarket Submissions4. Devices with Unique Issues –Combination Devices, Radiological Devices,Restricted Devices, Custom Devices,and Device Software5. In Vitro Diagnostic (IVD) Devices6. The Quality System Regulation7. Device Facility Inspections8. Postmarket Considerations9. International Considerations10. Interacting with FDA11. Enforcement and Government InvestigationsRelating to Medical Devices12. Continuing Medical Education (CME) andIndustry-Supported Scientific Activities13. Intellectual Property Considerations forMedical Device Companies14. Licensing, Product Developmentand Commercialization15. Fraudulent and Abusive Practices in theReimbursement for Medical Devices16. HIPAA's Impact on the Medical DeviceManufacturing Community17. Litigation, Products Liability, and Preemption18. FDA Criminal Enforcement19. Overlapping Jurisdiction with OtherAgencies and Law Enforcement Entities
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