Bringing Medical Devices to Market

Name: Bringing Medical Devices to Market
Brand: American Bar Association
Price: 127.99 EUR
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Charlene Cho(Herausgeber*in)

American Bar Association (Verlag)

Erschienen am 2. Mai 2022

420 Seiten

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978-1-64105-971-8 (ISBN)

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Inhalt

Intro
Title Page
Copyright Page
Contents
About the Editor
About the Authors
Introduction
Chapter 1: FDA Premarket Requirements
I. Overview of Device Regulation
A. Definitions
B. Intended Use
II. Classes of Medical Devices
A. Class I
B. Class II
C. Class III
III. Premarket Submissions
A. 510(k) Clearance
B. De Novo
C. Premarket Approval (PMA) Application
D. Humanitarian Device Exemption
E. Expedited Pathways: Breakthrough Device Program
IV. Evidence
A. Preclinical Testing
B. Early Feasibility Studies
C. Pivotal Trials and Clinical Studies
V. FDA Engagement during Product Development
A. Pre-Subs
B. Informational Meetings
C. 513(g) Requests for Information
D. Informal Digital Health Submissions
Chapter 2: FDA Regulation of Digital Health Care Products
I. Overview of Digital Health Products: Proliferation of Products and Services
II. Overview of FDA Authority over Software
A. Historical Position on Software as a Device
B. Clinical Decision Support Software (CDSS)
C. Software Incorporated in Devices
D. Stand-alone Software
E. Software as a Service
F. Unregulated Software
III. FDA Regulation of General Wellness Products
IV. Pre-Certification Program
V. Special Considerations for Software Submissions
A. Cybersecurity
1. Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software
2. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
B. Interoperability
VI. FDA's Approach to Algorithms and Deep Learning
VII. Conclusion
Chapter 3: Data, Clinical Trials, and Good Clinical Practices
I. Clinical Trials Generally
A. Clinical Studies Supporting Premarket Applications
1. Studies Supporting 510(k) Premarket Notifications
2. Studies Supporting De Novo Applications
3. Studies Supporting PMA Applications
4. Studies Supporting HDE Applications
B. Medical Device Clinical Study Phases
1. First-in-Human Studies
2. Early Feasibility Studies
3. Pilot Studies
4. Pivotal Studies
5. Other Premarket Studies
C. Postmarket Clinical Studies
1. Post-Approval Studies
2. Postmarket Surveillance
3. Postmarket Studies
4. Investigator-Initiated Studies
II. Good Clinical Practices
A. Generally
B. Electronic Records and Electronic Signatures (21 C.F.R. § 11)
C. Informed Consent, Protection of Human Subjects (21 C.F.R. § 50)
1. Exception from Informed Consent
D. Institutional Review Board (IRB) Review (21 C.F.R. § 56)
1. IRB Approval
E. Ethics-The Common Rule
F. Financial Disclosure by Clinical Investigators (21 C.F.R. § 54)
1. Disclosable Financial Interests and Certification
G. IDE Regulations (21 C.F.R. Part 812)
III. Investigational Device Exemptions (IDEs)
A. Regulations and Guidance
B. Study Risk Determination
1. Significant Risk (SR) Device
2. Nonsignificant Risk Devices
3. IDE-Exempt Devices
C. IDE Application
1. Pre-submission Filings
2. IDE Submission
D. FDA Interactions and IDE Review Process
1. Approval
2. Approval with Conditions
3. Disapproval
E. Sponsor Responsibilities and Recordkeeping
1. Sponsor Obligations
F. Investigator Responsibilities and Recordkeeping
G. Study Monitoring Requirements
H. Modifications to IDE Studies
1. Five-Day Notice of IDE Change
I. Termination of IDE Studies
J. IDE Annual Reports
K. Expanded Access
1. Emergency Use (§ 812.35(a))
2. Compassionate Use
3. Treatment IDE
4. Continued Access
IV. Study Design and Analysis
A. Types of Studies
1. Observational versus Interventional
2. Prospective versus Retrospective
3. Real-World Evidence (RWE)
4. Reader Studies
5. Single-Arm and Crossover Studies
B. Essential Study Design Parameters
1. Clinical Centers/Sites
2. Eligibility Criteria
3. Controls
4. Randomization
5. Blinding
6. Endpoints
7. Hypothesis and Success Criteria
8. Follow-up Visits and Duration
9. Procedures and Assessments
10. Statistical Considerations
C. Organizational Units
1. Mandatory
2. Optional
D. Clinical Study Reports
V. Study Conduct
A. Investigator and Site Selection
B. Investigator and Clinical Trial Agreements
C. Patient Recruitment
D. Study Monitoring
E. Quality Systems Approach to Clinical Trials
F. Standard Operating Procedures
G. Bioresearch Monitoring Audits
H. Reimbursement and Coverage Considerations
VI. Conclusions
Chapter 4: Intellectual Property Protections for Medical Devices
I. Initial Considerations of a Patent's Value
II. The Economic Value of a Patent
III. Three Principle Valuation Approaches
A. Income Approach
B. Cost Approach
C. Market Approach
D. Patent Valuation in the Context of Litigation
IV. Market Dynamics Play an Important Role in Determining a Patent's Value
A. Reimbursement Mechanisms for Medical Devices
B. Recent Shift in the Medical Device and Technology Industry toward Value-Based Payments
C. Design and Implementation of Value-Based Payment Systems for Medical Devices
D. Implications of Value-Based Payment Systems for Valuing Medical Device Patents
V. Monetization of a Medical Devices Patent
A. Sale of a Patent
B. Licensing of a Patent
C. Litigation of a Patent
Chapter 5: Business Arrangements and Contractual Agreements
I. Business Arrangements
A. Corporations and Limited Liability Companies
1. Formation Documents
2. Management
3. Ownership
4. Taxation
B. Partnerships
C. Choosing the Type of Entity
II. Common Agreements
A. Letter of Intent
B. Nondisclosure Agreement (NDA)
C. Licensing Agreement
D. Business Associate Agreement
E. Distribution Agreement
Appendix A
Appendix B
Appendix C
Appendix D
Appendix E
Chapter 6: Postmarket Requirements
I. Postmarket Requirements
II. Device Modifications
A. 510(k) Modifications
1. 510(k) Modification Decision-Making Process
2. Letters to File
B. PMA Modifications
1. When to Submit a Traditional PMA
2. Panel Track Supplement
3. 180-Day Supplement
4. Real-Time Supplement
5. 30-Day Notice
6. Manufacturing Site Change Supplement
7. Supplement: Special Changes Being Effected
III. Reporting
A. Annual Reporting
1. PMA Annual Report
B. Device Reporting
1. Reports of Corrections or Removals (806 Reporting)
C. Recalls
1. Recall versus Enhancement
2. Recall versus Stock Recovery and Market Withdrawal
3. Mandatory
4. Classification and Health Hazard Evaluation
5. Recall Database and Enforcement Report
D. Medical Device Reports (803 Reporting)
1. Manufacturer
2. User Facility
3. Importer
4. Voluntary
IV. Postmarket Studies
A. Post-Approval Studies
B. 522 Studies
C. Use of Real-World Data
V. Tracked Devices
VI. Unique Device Identification
A. Exceptions
VII. Regulatory Actions to Revise Applicable Requirements
A. Application of New Special Controls
B. Reclassification
Chapter 7: Compliance and Enforcement
I. Misbranding
II. Adulteration
III. FDA Inspections
IV. Inspection Process
V. Medical Device Single Audit Program (MDSAP)
VI. Form 483
VII. FDA Enforcement Actions
A. Letters to Industry
B. Recalls
C. Detention and Hearing
D. Import Alerts and Refusals
1. Import Refusals
E. Medical Device Bans
F. Civil Enforcement Litigation
G. Seizure
H. Injunctions
I. Civil Money Penalties
J. Criminal Prosecution and Criminal Fines
Chapter 8: Import/Exports
I. Introduction
A. Statutory Framework
FDCA Chapter VIII: Imports and Exports
B. Overview of the Chapter
II. Importing Devices into the United States
A. Statutory and Regulatory Requirements
1. Ex-U.S. Manufacturers and Imported Devices Must Meet All Requirements Applicable to Devices Manufactured in the United States
2. Designation of U.S. Agent
B. The Import Process
1. Role of FDA and CBP
2. The Importer of Record
3. The Entry Process
C. Detentions and Refusals of Admission
D. Product Sampling and Examination
E. Import Alerts, Detention without Physical Examination (DWPE)
F. Import for Export
G. Popular Topics
1. Importation of Goods for Personal Use
2. Foreign Trade Zones
3. Importing through U.S. Mail
III. Exporting Devices from the U.S.
A. Statutory and Regulatory Requirements
B. Export of Devices Legally Marketed in the U.S.
1. Certificate to Foreign Government
C. Export of Unapproved Class I and Certain Class II Devices under FDCA 801(e)(1)
1. Certificate of Exportability
2. "For Export Only" Labeling
D. Exporting Devices While Waiting for FDA Clearance
E. Exporting Unapproved Class III and Certain Class II Devices under Section 802
1. Device Must Have Valid Marketing Authorization in a "Listed Country"
2. Device Must Meet Requirements in 801(e)(1) and 802(f)
3. Firm Must Notify FDA When Export Begins
4. Firms Must Maintain Records of Export
5. Certificate of Exportability
F. Exporting Unapproved Class III and Certain Class II Devices under Section 801(e)(2)
1. Export Permit Letter
G. Exporting Unapproved Devices for Investigational Use
H. Exporting Devices for Further Processing under Section 802(d)
I. Exporting Devices for Tropical and Other Diseases Not of Significant Prevalence under Section 802(e)
IV. Actions and Enforcement
A. Import Alerts for GMP Violations, Inspection Refusals
Chapter 9: Fraud and Abuse Laws
I. Introduction
II. The False Claims Act
A. Brief History
B. Violative Conduct
C. Elements of a FCA Violation
D. Damages and Penalties
E. The Whistleblower Provision
III. The Anti-Kickback Statute
A. Legislative History
B. Violative Conduct
C. Elements of an AKS Violation
D. Safe Harbors
E. Special Fraud Alerts
F. Penalties and Damages
IV. Other Fraud and Abuse Considerations
A. The Physician Payments Sunshine Act
B. The Physician Self-Referral Law
V. Reducing the Risk of Health Care Fraud and Abuse
A. DOJ Policy Regarding Investigations of Corporate Wrongdoing
B. DOJ Criminal Division Guidance: Evaluation of Corporate Compliance Programs
C. OIG Guidance: Oversight of Compliance Program by Board of Directors
D. AdvaMed Code of Ethics
Chapter 10: Coverage, Coding, and Reimbursement for Medical Devices
I. Introduction
II. Coverage: Will Medicare Pay for a Device?
A. Benefit Categories
B. Statutory Exclusions
C. Reasonable and Necessary
D. Process for Making Coverage Decisions
E. Clinical Trials
1. Medicare Coverage of IDE Devices and Related Services
2. Medicare's NCD on Routine Costs in Clinical Trials
3. Coverage with Evidence Development
III. Coding: How Is a Device Identified on Claims?
A. Current Procedural Terminology Codes
B. HCPCS
C. ICD-10 Codes
IV. Reimbursement: How Medicare Pay for the Device?
A. Physician Fee Schedule
B. Hospital Outpatient Prospective Payment System
1. Pass-Through Payments
2. New Technology APCs
C. Ambulatory Surgical Center Payment System
D. Inpatient Prospective Payment System
E. End-Stage Renal Disease Prospective Payment System
F. Durable Medical Equipment Reimbursement
1. DMEPOS Fee Schedule
2. Competitive Bidding
V. Conclusion
Chapter 11: AI-Products Liability
I. Traditional Theories of Product Liability
A. Strict Liability
B. Breach of Warranty
C. Negligence
D. Common Defenses
1. Learned Intermediary
2. Preemption
II. Application of Product Liability Theories to Health Care AI
A. Product versus Software
B. Test to Determine Whether Health Care AI Is Defective
C. Potential Sources of Liability
D. Negligence: Standard of Care
E. Other Considerations
1. Black Box AI
2. Patient Informed Consent
3. Medical Malpractice
4. Data Privacy
F. Allocation of Responsibility
1. Contracting Responsibility
2. Joint and Several/Enterprise Liability
3. Legislative Regulation
G. Case Law from Other Industries
III. Conclusion
Index

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