Medical Devices Law and Regulation Answer Book

Medical Devices Law and Regulation Answer Book
Author: Susan Onel
Publisher:
Total Pages: 1112
Release: 2016-11
Genre: Medical instruments and apparatus
ISBN: 9781402427749
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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

Medical Devices Law and Regulation Answer
Author: Suzan Onel
Publisher: Practising Law Inst
Total Pages: 1014
Release: 2012
Genre: Law
ISBN: 9781402418372
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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

Medical Devices Law and Regulation Answer Book 2015
Author: Suzan Onel
Publisher:
Total Pages: 0
Release: 2014-10-07
Genre: Medical instruments and apparatus
ISBN: 9781402422607
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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

Medical Devices Law and Regulation Answer Book 2014
Author: Suzan Onel
Publisher:
Total Pages: 0
Release: 2013-11-07
Genre: Medical instruments and apparatus
ISBN: 9781402420498
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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 Device Regulations

Medical Device Regulations
Author: Michael Cheng
Publisher: World Health Organization
Total Pages: 54
Release: 2003-09-16
Genre: Medical
ISBN: 9241546182
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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

Medical Regulatory Affairs
Author: Jack Wong
Publisher: CRC Press
Total Pages: 806
Release: 2022-01-27
Genre: Medical
ISBN: 1000440516
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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 Regulations

Medical Device Regulations
Author: Aakash Deep
Publisher: Academic Press
Total Pages: 187
Release: 2022-01-13
Genre: Technology & Engineering
ISBN: 0323911277
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Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products

Inspection of Medical Devices

Inspection of Medical Devices
Author: Almir Badnjević
Publisher: Springer Nature
Total Pages: 441
Release: 2023-12-28
Genre: Technology & Engineering
ISBN: 3031434447
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This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!

Medical Device Safety

Medical Device Safety
Author: G.R Higson
Publisher: CRC Press
Total Pages: 278
Release: 2001-10-29
Genre: Medical
ISBN: 1420033980
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Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en