Medical Device Design and Regulation

Carl T. DeMarco

Description

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation.
There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use or for employee training. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Medical
• Médecine
• Biotechnology

Informations

• Publié par: ASQ Quality Press
• Date de parution: 24 janvier 2011
• Nombre de lectures: 1
• EAN13: 9780873891882
• Langue: English

Extrait

Medical Device Design and Regulation
Also available from ASQ Quality Press:
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
Amiram Daniel and Ed Kimmelman
CAPA for the FDA-Regulated Industry
José Rodríguez-Pérez
Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
Elaine Whitmore
Safe and Sound Software: Creating an Efficient and Effective Quality System for Software Medical Device Organizations
Thomas H. Faris
The Certified Quality Engineer Handbook, Third Edition
Connie M. Borror, editor
Root Cause Analysis: Simplified Tools and Techniques, Second Edition
Bjørn Andersen and Tom Fagerhaug
Mastering and Managing the FDA Maze: Medical Device Overview
Gordon Harnack
Root Cause Analysis: The Core of Problem Solving and Corrective Action
Duke Okes
Get It Right: A Guide to Strategic Quality Systems
Ken Imler
The Internal Auditing Pocket Guide: Preparing, Performing, Reporting, and Follow-up, Second Edition
J.P. Russell
Measurement Matters: How Effective Assessment Drives Business and Safety Performance
Brooks Carder and Patrick Ragan
The Quality Toolbox, Second Edition
Nancy R. Tague
To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our website at www.asq.org/quality-press .
Medical Device Design and Regulation
Carl T. DeMarco
ASQ Quality Press
Milwaukee, Wisconsin
American Society for Quality, Quality Press, Milwaukee 53203
© 2011 by ASQ
All rights reserved. Published 2011

Library of Congress Cataloging-in-Publication Data
DeMarco, Carl T.
Medical device design and regulation / Carl T. DeMarco.
p. cm.
Includes bibliographical references and index.
ISBN 978-0-87389-816-4 (hbk. : alk. paper)
1. Medical instruments and apparatus—United States. 2. Medical instruments and apparatus—United States—Design and construction. 3. Medical instruments and apparatus—Safety regulations—United States. 4. Medical instruments and apparatus industry—United States. I. Title.
R856.D437 2011
610.28 ’ 4—dc22 2011003881
ISBN: 978-0-87389-816-4
No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.
Publisher: William A. Tony
Acquisitions Editor: Matt T. Meinholz
Project Editor: Paul O’Mara
Production Administrator: Randall Benson
ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005.
To place orders or to request ASQ membership information, call 800-248-1946. Visit our website at http://www.asq.org/quality-press .
Table of Contents
Medical Device Design and Regulation
Medical Device Design and Regulation
List of Figures and Tables
List of Abbreviations
Introduction
Medical Device Regulatory Requirements
Purpose of Medical Device Design and Regulation
Students
Medical Device Practitioners
Device Design and Innovation
A Risk-Based Regulatory System
International Aspects of Medical Device Regulation
Learning Aides
Field Testing
Caveats
Disclaimer
Acknowledgments
Chapter 1: Background and Regulatory Environment
Part 1. Medical Device Design and Development
Section 1. Major Steps in the Design and Development of a Medical Device
Section 2. Teamwork in Industry and FDA
Section 3. Medical Device Quality, Safety, and Effectiveness
Part 2. The Medical Device Industry
Section 1. Industry Demographics
Section 2. Medical Device Innovations
Section 3. The Regulated Industry
Part 3: United States Food and Drug Administration
Section 1. Organizational Structure
Section 2. FDA Decision Making
Section 3. CDRH Strategic Priorities and Transparency
Section 4. Division of Small Manufacturers, International and Consumer Assistance
Section 5. FDA Foreign Offices
Part 4. The Legal Basis for Device Regulation
Section 1. Interstate Commerce
Section 2. The Federal Food, Drug, and Cosmetic Act (FDCA) and Its Evolution
Section 3. The Medical Device Amendments of 1976
Part 5. Quasi-Legal Requirements
Section 1. Voluntary/Consensus Standards
Section 2. FDA-Recognized Standards
Section 3. Mandatory Standards
Section 4. Guidance Documents
Part 6. FDA Administrative Actions
Section 1. FDA Regulations
Section 2. Mandatory Standards
Section 3. Administrative Hearings
Part 7. Judicial Review
Section 1. Agency Enforcement Actions
Section 2. Challenging Agency Actions
Part 8. State Regulation of Medical Devices
Section 1. Model Uniform State Food, Drug, and Cosmetic Act
Section 2. Preemption of State Laws and Regulations
Part 9. International Aspects of Device Regulation
Section 1. European Union Medical Device Regulation
Section 2. Global Harmonization Task Force
Section 3. Other Requirements with International Implications
Part 10. Confidentiality and Nonpublic Information
Section 1. Nonpublic Information
Section 2. Trade Secrets
Section 3. Confidential Commercial Information
Section 4. Financially Sensitive Information
Section 5. Specific Patient Information
Section 6. Specific Employee Information
Section 7. Protecting Nonpublic Information
Part 11. Monitoring and Auditing
Section 1. Monitoring
Section 2. Auditing
Part 12. Patents
Part 13. Medical Devices, Drugs, and Biologics
Section 1. Medical Devices
Section 2. Drug Products
Section 3. Biological Products
Section 4. Classification of Medical Devices
Section 5. Classes of Medical Devices
Section 6. Class I and Class II Device Exemptions
Section 7. Restricted and Prescription Devices
Section 8. Combination Products
Section 9. Custom Devices
Part 14. Exercises
Chapter 2: Medical Device Design
Part 1. Design Control Background
Section 1. Overview of Design Control
Section 2. Applicability of FDA’s Design Regulation
Section 3. International Design Control Standards
Part 2. Design Planning and Record Keeping
Section 1. Design Planning
Section 2. Design History File
Part 3. Design Inputs and Outputs
Section 1. Design Inputs
Section 2. Human Factors Engineering
Section 3. Design Outputs
Part 4. Design Verification and Design Validation
Section 1. Verification
Section 2. Validation
Part 5. Design Review and Documentation
Part 6. Design Transfer and Design Changes
Section 1. Design Transfer
Section 2. Design Changes
Section 3. Documentation of Design Change
Part 7. Design Failures
Part 8. Exercises
Chapter 3: Nonclinical Testing and GLPs
Part 1. Nonclinical Testing
Section 1. General Principles
Section 2. SOPs and Protocols
Section 3. Device Description
Section 4. Performance Testing
Section 5. Animal Experimentation and Evaluation
Section 6. Biocompatibility
Section 7. Sterility and Shelf Life
Part 2. Good Laboratory Practice
Section 1. Scope and Applicability
Section 2. The GLP Regulatory Scheme
Section 3. Organization and Personnel
Section 4. Facilities
Section 5. Equipment
Section 6. Testing Facilities Operations
Section 7. Test and Control Articles
Section 8. Protocols
Section 9. Records and Reports
Section 10. Disqualification of Testing Facilities
Part 3. Exercises
Chapter 4: Clinical Trials
Good Clinical Practices
Biostatistics
Part 1. Background Information
Section 1. Regulatory Scheme
Section 2. International Guidelines for Medical Device Research
Section 3. Major Clinical Trial Participants and Definitions
Section 4. Ethics in Clinical Trials
Section 5. Bias and Financial Conflicts of Interest
Section 6. Monitoring and Auditing a Clinical Trial
Section 7. Controls for Clinical Trials
Part 2. Clinical Trial Design
Section 1. The Investigational Plan
Section 2. The Clinical Trial Protocol
Section 3. Blinding
Section 4. Study Controls
Section 5. Number of Patients and Study Sites
Section 6. Proving Safety and Effectiveness and Substantial Equivalence
Part 3. Informed Consent
Section 1. General Applicability
Section 2. IRB and FDA Review and Approval of Informed Consent Form
Section 3. Elements of Informed Consent
Section 4. Documentation of Informed Consent
Section 5. Emergency Use Exception from Informed Consent
Section 6. Special Safeguards for Children
Section 7. In Vitro Diagnostic Device (IVD) Testing
Part 4. Institutional Review Boards
Section 1. IRB Structure and Membership
Section 2. IRB Duties and Responsibilities
Section 3. FDA Actions for Noncompliance by the IRB
Part 5. Investigational Device Exemptions
Section 1. Purpose of the IDE Regulation
Section 2. The Role of Engineers and Other Scientists in Clinical Studies
Section 3. Applicability
Section 4. Exempted Studies
Section 5. Significant Risk Studies
Section 6. Responsibilities of Sponsors
Section 7. Responsibilities of Investigators
Section 8. FDA Actions on IDE Applications
Section 9. IDE Prohibitions
Section 10. Treatment Use of an Investigational Device
Section 11. Confidentiality of IDE Data
Section 12. Nonsignificant Risk (NSR) Studies
Part 6. Bioresearch Monitoring
Section 1. BIMO Inspections
Section 2. Clinical Study Deficiencies
Section 3. BIMO Enforcement Actions
Part 7. Importing and Exporting Medical Devices for Investigational Use
Section 1. Importing an Investigational Device
Section 2. Exporting an Investigational Device
Part 8. National Clinical Trials Data Bank
Section 1. Background and Pu