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Medical Devices Law and Regulation Answer Book by Susan Onel,Karen M. Becker Pdf
This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Medical Devices Law and Regulation Answer by Suzan Onel,Karen Becker Pdf
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 2013 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 2013 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. The breadth of coverage of this new publication is illustrated by the chapter titles provided below: Overview of Medical Device Regulation in the U.S. Clinical Studies of Investigational Devices Device Premarket Submissions Devices with Unique Issues Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software In Vitro Diagnostic (IVD) Devices The Quality System Regulation Device Facility Inspections Post Market Considerations International Considerations Enforcement and Government Investigations Regarding Medical Devices Interacting with FDA Intellectual Property Considerations for Medical Device Companies Fraudulent and Abusive Practices in the Reimbursement for Medical Devices HIPAA s Impact on the Medical Device Manufacturing Community Continuing Medical Education (CME) and Industry-Supported Scientific Activities Litigation, Product Liability, and Preemption Licensing, Product Development and Commercialization FDA Criminal Enforcement Overlapping Jurisdiction with other Agencies and Law Enforcement Entities Commonly Used Acronyms"
Medical Devices Law and Regulation Answer Book 2015 by Suzan Onel,Karen M. Becker Pdf
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. This title 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. Topics include: Overview of Medical Device Regulation in the U.S; Clinical Studies of Investigational Devices; Device Premarket Submissions; Devices with Unique Issues Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software; Licensing, Product Development and Commercialization * FDA Criminal Enforcement * Overlapping Jurisdiction with other Agencies and Law Enforcement Entities * Commonly Used Acronyms"
Medical Devices Law and Regulation Answer Book 2014 by Suzan Onel,Karen M. Becker Pdf
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. This title 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. Topics include: Overview of Medical Device Regulation in the U.S; Clinical Studies of Investigational Devices ; Device Premarket Submissions; Devices with Unique Issues - Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software; Licensing, Product Development and Commercialization * FDA Criminal Enforcement * Overlapping Jurisdiction with other Agencies and Law Enforcement Entities * Commonly Used Acronyms"
Medical Product Regulatory Affairs by John J. Tobin,Gary Walsh Pdf
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Medical Device Regulations by Michael Cheng,World Health Organization Pdf
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Medical Regulatory Affairs by Jack Wong,Raymond K. Y. Tong Pdf
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Medical Device Regulatory Practices by Val Theisz Pdf
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.
AHLA Pharmaceutical and Medical Device Compliance Manual (AHLA Members) by Anonim Pdf
The fight against fraud and abuse in healthcare programs, and the pharmaceutical and medical devices industry in particular, continues to grow. Since 1996 the federal government has strengthened its efforts to detect and prevent fraud and abuse in healthcare, and has recovered $18 billion since 1997. These enforcement activities make a compliance program essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies do that.Coverage includes:In-depth coverage of the federal and state enforcement agenciesFederal Anti-Kickback Statute and False Claims Act detailsDistinction between manufacturers' lawful dissemination of scientific information and unlawful promotion of off-label useDiscussion of the Foreign Corrupt Practices Act and its extra-territorial reachCoverage and reimbursement of prescription drugs and medical devicesPrescription drug price regulationsThe Manual includes guidance on building an effective compliance program and will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry.EDITORSKathleen M. Boozang, J.D., LL.M., Professor of Law, SETON HALL LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJSimone Handler-Hutchinson, J.D., Executive Director, SETON HALL LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJCONTRIBUTING AUTHORSBret A. Campbell, Esquire; Cadwalader, Wickersham & Taft LLP, Washington, DC; Sujata Dayal, Esquire; Biomet, Inc., Warsaw, IN; Michael Andre Donnella, Esquire; Wyeth, Madison, NJ; Katie Rose Fink, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Brett R. Friedman, Esquire; Ropes & Gray, LLP, New York. NY; Gary F. Giampetruzzi, Esquire; Pfizer, Inc., New York, NY; Christopher R. Hall, Esquire; Saul Ewing, LLP, Philadelphia, PA; Patrick M. Hromisin, Esquire; Saul Ewing, LLP, Philadelphia, PA; Elizabeth H. Kim, Esquire; Porzio Life Sciences, LLC, Morristown, NJ; Daniel A. Kracov, Esquire; Arnold & Porter, LLP; Washington, DC; Bruce A. Levy, Esquire; Gibbons, PC., Newark, NJ; Ann E. Lewis, Esquire; Ropes & Gray, LLP, New York. NY; Benjamin S. Martin, Esquire; Epstein Becker & Green, PC, Washington, DC; Joseph W. Metro, Esquire; Reed Smith, LLP, Washington, DC; Lewis Morris, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Kiaema R. Reid; Porzio Life Sciences, LLC, Morristown, NJ; Linda Pissott Reig, Esquire; Buchanan Ingersoll & Rooney, PC, Newark, NJ; Margaret Renner, Esquire; FDA (formerly Arnold & Porter), Silver Spring, MD; Mary Riordan, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Lynn Shapiro Snyder, Esquire; Epstein Becker & Green, PC, Washington, DC; Brian Tretick; Athena Privacy, LLC, Washington, DC; Robert E. Wanerman, Esquire; Epstein Becker & Green, PC, Washington, DC; and Mara E. Zazzali-Hogan, Esquire, Gibbons, PC., Newark, NJ
