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.

Part 4. Medical Device Recalls.