Medical device design and regulation

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Bibliographic Details
Main Author DeMarco, Carl T. (Author)
Format Electronic eBook
LanguageEnglish
Published Milwaukee, Wisconsin : ASQ Quality Press, 2011.
Subjects
United States. > Food and Drug Administration.
United States > Food and Drug Administration
United States. > Food and Drug Administration
Medical instruments and apparatus > United States.
Medical instruments and apparatus > United States > Design and construction.
Medical instruments and apparatus > Safety regulations > United States.
Medical instruments and apparatus industry > United States.
Social control.
Public health.
Sociology.
Medical care.
Social sciences.
elektronické knihy
electronic books
Online AccessFull text
ISBN9780873898164
0873898168
9781621980766
1621980766
6000049307
9786000049300
9780873891882
0873891880
Physical Description1 online resource (368 pages) : illustrations

Cover

Table of 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 1. Applicability and Scope
  • Section 2. Devices Subject to Tracking
  • Section 3. The Tracking Process
  • Section 4. Records and Reports.

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