Medical device design and regulation / Carl T. DeMarco.

Format:

Book

Author/Creator:

DeMarco, Carl T., author.

Language:

English

Subjects (All):

Medical instruments and apparatus--United States.

Medical instruments and apparatus.

Medical instruments and apparatus--United States--Design and construction.

Medical instruments and apparatus--Safety regulations--United States.

Medical instruments and apparatus industry--United States.

Medical instruments and apparatus industry.

Physical Description:

1 online resource (368 p.)

Edition:

1st ed.

Place of Publication:

Milwaukee, Wisconsin : ASQ Quality Press, 2011.

Language Note:

English

Summary:

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.

Contents:

Intro

Title Page

CIP data

Dedication

Table of Contents

List of Figures and Tables

List of Abbreviations

Introduction

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. CD RH 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. SO Ps 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 LaboratoryPractice

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. IR B 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 Scientistsin 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 Purpose

Section 2. Exempted Clinical Trials

Section 3. FDA Certification

Part 9. Exercises

Chapter 5: Marketing Applications

The Scope of This Chapter

Early Planning

Part 1. Global Marketing Application Concepts

Section 1. Overview of the Premarket Review Process

Section 2. Valid Scientific Evidence

Section 3. Labeling and Unapproved Uses

Section 4. Advisory Committee Review and Outside Expertise

Section 5. Intermediate FDA Actions During the Review Process

Section 6. Financial Disclosure

Section 7. Data Integrity

Section 8. Bioresearch Monitoring

Section 9. CDRH Electronic Copy Initiative

Section 10. Medical Device User Fees

Section 11. CDRH Premarket Review Submission Cover Sheet

Part 2. Premarket Notification (510[k]).

Section 1. Background

Section 2. Applicability

Section 3. Types of 510(k)s

Section 4. The 510(k) and Substantial Equivalence

Section 5. FDA Action on a 510(k)

Section 6. Marketing a 510(k) Device

Section 7. Custom Device Exemption

Section 8. Request under Section 513(g) of the Act

Section 9. Upcoming 510(k) Program Changes

Part 3. PMAs/PDPs/HDEs

Section 1. PMA Overview

Section 2. Original PMA Submissions

Section 3. Format and Content of a PMA Submission

Section 4. The Determination of Safety and Effectiveness and the Summary of Safety and Effectiveness Data

Section 5. PMA Meetings

Section 6. FDA Actions

Section 7. PMA Conditions of Approval Requirements

Section 8. Post-Approval Reports

Section 9. Adverse Reaction and Device Defect Reporting

Section 10. Post-Approval Studies

Section 11. PMA Supplements

Section 12. Product Development Protocols

Section 13. Humanitarian Device Exemptions

Part 4. Importing and Exporting Medical Devices for Commercial Distribution

Section 1. Importing a Medical Device

Section 2. Exporting a Medical Device

Part 5. Exercises

Chapter 6: Post-Market Requirements

Part 1. Medical Device Reporting

Section 1. Applicability and Reportable Events

Section 2. Reporting Responsibilities

Section 3. Standard Operating Procedures for MDR

Section 4. Record-Keeping Requirements

Section 5. Exemptions, Variances, and Alternative Reporting Requirements

Section 6. Public Disclosure of MDR Information

Part 2. Post-market Surveillance Studies

Section 1. Applicability and Scope

Section 2. The PS Submission and PS Plan

Section 3. FDA Actions

Part 3. Medical Device Tracking

Section 2. Devices Subject to Tracking

Section 3. The Tracking Process

Section 4. Records and Reports.

Part 4. Medical Device Recalls.

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on print version record.

ISBN:

9780873891875

0873891872

9780873891882

0873891880

9786000049300

6000049307

OCLC:

893681506