FDA and Intellectual Property Strategies for Medical Device Technologies.

By: Halt, Gerald BContributor(s): Donch, John C | Stiles, Amber R | VanLuvanee, Lisa Jenkins | Theiss, Brandon R | Blue, Dana LMaterial type: TextTextSeries: eBooks on DemandPublisher: Cham : Springer International Publishing AG, 2019Copyright date: ©2019Description: 1 online resource (339 pages)Content type: text Media type: computer Carrier type: online resourceISBN: 9783030044626Subject(s): Medical technology | Pharmaceutical policy | Intellectual propertyGenre/Form: Electronic books.Additional physical formats: Print version:: FDA and Intellectual Property Strategies for Medical Device TechnologiesDDC classification: 610.28 LOC classification: TA1-2040Online resources: Click here to view this ebook.
Contents:
Intro -- Preface -- Acknowledgments -- About the Book -- Examples and Illustrations Throughout This Book -- Contents -- List of Figures -- List of Tables -- About the Authors -- Chapter 1: Introduction -- 1.1 Part I: FDA Strategies for Medical Device Technology -- 1.2 Part II: Overview of Intellectual Property Rights for Medical Device Technology -- 1.3 Implementation Strategies for Medical Device Innovators -- Part I: FDA Strategies for Medical Device Technology -- Chapter 2: General Overview of Development Process -- 2.1 History of Medical Device Regulation in the United States -- 2.2 Regulatory Definitions -- 2.2.1 What Is a Medical Device? -- 2.2.1.1 Components and Accessories -- 2.2.2 What Is a Drug? -- 2.2.3 What Is a Biologic? -- 2.2.4 What Is a Combination Product? -- 2.2.5 What Is an In Vitro Diagnostic (IVD)? -- 2.2.6 What Is a Medical Device Data System (MDDS)? -- 2.3 Inventing a Medical Device -- 2.3.1 Concept Development and Indication for Use -- 2.3.2 Design Development -- 2.3.3 Prototype Development -- 2.4 Device Classifications and Regulatory Pathways -- 2.4.1 What Class Is My Device? -- 2.4.1.1 Components and Accessories -- 2.4.2 Exempt from Premarket Submission -- 2.4.3 Premarket Notification -- 2.4.3.1 510(k) Application -- 2.4.3.2 Premarket Approval Application (PMA) -- 2.4.3.3 De Novo Process -- 2.4.3.4 Humanitarian Device Exemption (HDE) Pathway -- 2.4.4 Combination Products -- References -- Chapter 3: FDA Meetings and Device Testing -- 3.1 Interactions with the FDA -- 3.1.1 Publicly Available Information -- 3.1.2 Talking with FDA: U.S. Agent -- 3.1.3 Speaking with the FDA: Device-Specific Guidance -- 3.1.4 History of FDA Meeting Types -- 3.1.5 Today's Medical Device Meetings with FDA -- 3.1.5.1 Pre-Submissions -- 3.1.5.2 Submission Issue Requests -- 3.1.5.3 Study Risk Determinations -- 3.1.5.4 Informational Meetings.
3.1.5.5 Other Q-Subs -- PMA Day 100 Meetings -- Formal Early Collaboration Meetings -- 3.1.5.6 Submission Issue Meetings -- 3.1.6 Who Should Attend an FDA Meeting? -- 3.1.7 Guidelines for Interacting with the FDA -- 3.1.8 What Types of Questions Should Be Asked (and Not Asked)? -- 3.2 Establishing the Predicate -- 3.2.1 Establishing Equivalence -- 3.3 Nonclinical Research -- 3.4 Investigational Device Exemption Application (IDE) -- 3.5 Clinical Research -- 3.6 Human Factor and Usability Engineering -- 3.6.1 What You Need to Consider -- 3.6.1.1 Who Will Use This Device? -- 3.6.1.2 Where Will Your Device Be Used? -- 3.6.1.3 What Are the Critical Tasks and Use-Related Hazards? -- 3.6.2 Reducing Risks: Mitigation Strategies for Identified Risks -- 3.6.3 HF Validation Testing -- References -- Chapter 4: Compiling and Submitting Your Device Application -- 4.1 Compiling Your Submission Package -- 4.1.1 General Guidelines -- 4.1.1.1 eCopy -- 4.1.2 Premarket Notification 510(k) Submissions -- 4.1.2.1 Elements of All 510(k) Applications -- 4.1.2.2 Traditional 510(k) Application -- 4.1.2.3 Abbreviated 510(k) Application -- 4.1.2.4 Special 510(k): Device Modification -- 4.1.3 Premarket Approval (PMA) -- 4.1.4 De Novo Applications -- 4.1.5 Combination Product Applications -- 4.2 Device Labeling Requirements -- 4.2.1 Standard Requirements for Medical Device Labeling -- 4.2.2 Combination Product Labeling -- 4.2.3 Unique Device Identification: A New Labeling Requirement (21 C.F.R. 830) -- 4.2.4 Device Labeling Examples -- 4.2.4.1 Label Content Comparison of Five Currently Marketed Products -- 4.2.5 Misbranding -- 4.3 User Fees -- References -- Chapter 5: During and After Review -- 5.1 FDA Review of Your Device Application -- 5.1.1 FDA Review Process -- 5.1.1.1 Additional Information Letter (Deficiencies Noted During Review) -- 5.1.2 510(k) Review Process.
5.1.3 PMA Review Process -- 5.1.3.1 Summary of Safety and Effectiveness Data (SSED) -- 5.1.4 De Novo Review Process -- 5.1.5 Combination Products -- 5.2 Advertising and Promoting Your Device -- 5.3 Post-Marketing Requirements -- 5.3.1 Post-Market Safety Monitoring and Reporting -- 5.3.1.1 Mandatory Medical Device Reporting (MDR) -- 5.3.1.2 Voluntary Medical Device Adverse Event Reporting -- 5.3.1.3 MedSun -- 5.3.2 Post-Marketing Study Requirements -- 5.3.3 The Future of Post-Marketing Safety Surveillance -- 5.3.4 Periodic (Annual) Reports -- 5.3.5 Medical Device and Establishment Registration -- 5.3.6 Medical Device Tracking -- 5.3.7 Record Keeping Requirements -- 5.4 Product Updates -- 5.4.1 Updates to 510(k)s -- 5.4.1.1 Determining Impact to Safety and Effectiveness of the Device -- 5.4.2 Updates to PMAs -- 5.5 Recalls, Corrections, and Removal of Devices -- 5.5.1 Voluntary Device Recall -- 5.5.2 Mandatory Device Recalls -- 5.5.3 Device Corrections and Removals -- References -- Part II: Overview of Intellectual Property Rights for Medical Device Technology -- Chapter 6: Patents -- 6.1 Patent Protection as an Intellectual Property Strategy for Medical Device Technology -- 6.1.1 Research Agreements -- 6.1.2 Making an Invention Disclosure Statement to Your Patent Attorney -- 6.2 Patentability Requirements in the United States -- 6.2.1 Patentable Subject Matter -- 6.2.2 Invention Has Utility -- 6.2.3 Invention Is Novel -- 6.2.4 Invention Is Non-Obvious -- 6.3 Public Disclosures -- 6.4 Provisional Applications -- 6.5 Non-Provisional Applications -- 6.5.1 The Anatomy of a Patent Application -- 6.5.1.1 Claims -- 6.5.1.2 Specification -- 6.5.2 The "Duty to Disclose" -- 6.5.3 Assignment of Patent Rights -- 6.5.4 Inventorship vs. Ownership -- 6.5.4.1 Inventorship -- 6.5.4.2 Ownership -- 6.5.5 What to Expect: The Patent Application Examination Process.
6.5.6 Continuing Applications -- 6.6 Going Global: International Patent Considerations -- 6.6.1 Patent Cooperation Treaty (PCT) -- 6.7 Clearly Defining Over Crowded Prior Art -- 6.7.1 Avoiding Design-Arounds with Broad Claims -- 6.8 Unique Patent Challenges for Medical Devices -- 6.8.1 Medical Device Claims vs. Medical Device Use Claims -- 6.8.2 Diagnostic Methods -- 6.8.3 Methods of Treatment -- 6.8.4 Medical Device Software -- 6.9 Getting Patent Term Extension for Medical Devices -- 6.10 Post Allowance Challenges -- 6.10.1 Post Grant Review -- 6.10.2 Inter Partes Review (IPR) -- 6.10.3 Ex Parte Reexamination -- References -- Chapter 7: Trademarks -- 7.1 Trademarks in Medical Device Technology -- 7.2 What Is a Trademark? -- 7.3 Non-Protectable Subject Matter -- 7.4 Selecting a Trademark -- 7.4.1 Brainstorming Phase -- 7.4.2 Narrowing Phase -- 7.4.3 Knockout Phase -- 7.4.4 Clearance Search -- 7.4.5 Obtaining a Legal Opinion -- 7.5 Protecting a Trademark -- 7.5.1 Common Law of Trademark -- 7.5.2 Federal Trademark Protection -- 7.5.2.1 The Federal Trademark Application Requirements -- 7.5.2.2 Examination -- 7.5.3 State Registration -- 7.5.4 International Protection -- 7.5.4.1 Madrid Protocol -- 7.5.4.2 European Union Trademark -- 7.6 Maintaining Trademark Rights -- 7.6.1 Maintaining Federal Registration -- 7.6.2 Licensing Trademarks -- 7.6.3 Assignment of Trademarks -- 7.6.4 Policing Trademark Use -- 7.6.4.1 Genericide -- References -- Chapter 8: Trade Secrets -- 8.1 Secrecy Creates Value: How Medical Device Innovators Utilize Trade Secret Protection -- 8.2 What Are Trade Secrets? -- 8.3 Independent Discovery and Reverse Engineering of Trade Secrets -- 8.4 Theft of Trade Secrets: Misappropriation -- 8.4.1 Defense of Trade Secrets Act -- 8.4.2 Corporate Espionage -- 8.4.3 Employee Poaching -- 8.4.4 Cyber Theft -- References.
Chapter 9: Copyrights in Medical Device Technology -- 9.1 Copyrightable Subject Matter in Medical Technology -- 9.2 Scope of Protection -- 9.2.1 Software and Apps as Copyrightable Matter -- 9.2.2 Advertising, Marketing Materials and Product Packaging -- 9.2.3 Training Manuals, User Manuals and the Like -- 9.2.4 Trade Secrets and Other Materials Including Software -- 9.2.5 Data and Databases -- 9.3 Ownership and Authorship -- 9.3.1 Works for Hire -- 9.3.2 Jointly Authored Works -- 9.4 Licensing and Assignment of Copyrights -- 9.5 Derivative Works -- 9.6 Fair Use -- 9.7 Registration Issues -- 9.8 International Copyright Protection -- 9.8.1 The Berne Convention for the Protection of Literary and Artistic Works -- 9.8.2 Universal Copyright Convention -- References -- Chapter 10: Design Protection for Medical Devices -- 10.1 Design Patents for Medical Devices -- 10.1.1 Requirements for Design Patents -- 10.1.2 Protection Afforded by Design Patents -- 10.1.2.1 Priority Claims for Design Patents -- 10.1.3 Design Patent Disputes -- 10.1.3.1 Apple v. Samsung -- 10.2 International Design Protection -- 10.2.1 Design Protection in Europe -- 10.2.2 Design Protection in Asian Countries -- 10.2.3 The Hague Agreement -- 10.3 Importance of Protecting Medical Device Designs -- 10.3.1 Graphical User Interfaces and Icon Designs -- 10.3.2 Replacement/Consumable Parts -- References -- Chapter 11: Intellectual Property Issues in Medical Device Labeling and Marketing -- 11.1 Government Controls Over Medical Device Advertisements and Labeling -- 11.1.1 Food and Drug Administration -- 11.1.2 Federal Trade Commission -- 11.1.3 State Regulation -- 11.1.4 Government Controls Abroad -- 11.1.5 Patent Marking -- 11.2 Non-Government Controls -- 11.3 Comparative Advertising -- References -- Chapter 12: Enforcement, Infringement and Monetization of Intellectual Property Rights.
12.1 Policing Your IP Rights.
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Intro -- Preface -- Acknowledgments -- About the Book -- Examples and Illustrations Throughout This Book -- Contents -- List of Figures -- List of Tables -- About the Authors -- Chapter 1: Introduction -- 1.1 Part I: FDA Strategies for Medical Device Technology -- 1.2 Part II: Overview of Intellectual Property Rights for Medical Device Technology -- 1.3 Implementation Strategies for Medical Device Innovators -- Part I: FDA Strategies for Medical Device Technology -- Chapter 2: General Overview of Development Process -- 2.1 History of Medical Device Regulation in the United States -- 2.2 Regulatory Definitions -- 2.2.1 What Is a Medical Device? -- 2.2.1.1 Components and Accessories -- 2.2.2 What Is a Drug? -- 2.2.3 What Is a Biologic? -- 2.2.4 What Is a Combination Product? -- 2.2.5 What Is an In Vitro Diagnostic (IVD)? -- 2.2.6 What Is a Medical Device Data System (MDDS)? -- 2.3 Inventing a Medical Device -- 2.3.1 Concept Development and Indication for Use -- 2.3.2 Design Development -- 2.3.3 Prototype Development -- 2.4 Device Classifications and Regulatory Pathways -- 2.4.1 What Class Is My Device? -- 2.4.1.1 Components and Accessories -- 2.4.2 Exempt from Premarket Submission -- 2.4.3 Premarket Notification -- 2.4.3.1 510(k) Application -- 2.4.3.2 Premarket Approval Application (PMA) -- 2.4.3.3 De Novo Process -- 2.4.3.4 Humanitarian Device Exemption (HDE) Pathway -- 2.4.4 Combination Products -- References -- Chapter 3: FDA Meetings and Device Testing -- 3.1 Interactions with the FDA -- 3.1.1 Publicly Available Information -- 3.1.2 Talking with FDA: U.S. Agent -- 3.1.3 Speaking with the FDA: Device-Specific Guidance -- 3.1.4 History of FDA Meeting Types -- 3.1.5 Today's Medical Device Meetings with FDA -- 3.1.5.1 Pre-Submissions -- 3.1.5.2 Submission Issue Requests -- 3.1.5.3 Study Risk Determinations -- 3.1.5.4 Informational Meetings.

3.1.5.5 Other Q-Subs -- PMA Day 100 Meetings -- Formal Early Collaboration Meetings -- 3.1.5.6 Submission Issue Meetings -- 3.1.6 Who Should Attend an FDA Meeting? -- 3.1.7 Guidelines for Interacting with the FDA -- 3.1.8 What Types of Questions Should Be Asked (and Not Asked)? -- 3.2 Establishing the Predicate -- 3.2.1 Establishing Equivalence -- 3.3 Nonclinical Research -- 3.4 Investigational Device Exemption Application (IDE) -- 3.5 Clinical Research -- 3.6 Human Factor and Usability Engineering -- 3.6.1 What You Need to Consider -- 3.6.1.1 Who Will Use This Device? -- 3.6.1.2 Where Will Your Device Be Used? -- 3.6.1.3 What Are the Critical Tasks and Use-Related Hazards? -- 3.6.2 Reducing Risks: Mitigation Strategies for Identified Risks -- 3.6.3 HF Validation Testing -- References -- Chapter 4: Compiling and Submitting Your Device Application -- 4.1 Compiling Your Submission Package -- 4.1.1 General Guidelines -- 4.1.1.1 eCopy -- 4.1.2 Premarket Notification 510(k) Submissions -- 4.1.2.1 Elements of All 510(k) Applications -- 4.1.2.2 Traditional 510(k) Application -- 4.1.2.3 Abbreviated 510(k) Application -- 4.1.2.4 Special 510(k): Device Modification -- 4.1.3 Premarket Approval (PMA) -- 4.1.4 De Novo Applications -- 4.1.5 Combination Product Applications -- 4.2 Device Labeling Requirements -- 4.2.1 Standard Requirements for Medical Device Labeling -- 4.2.2 Combination Product Labeling -- 4.2.3 Unique Device Identification: A New Labeling Requirement (21 C.F.R. 830) -- 4.2.4 Device Labeling Examples -- 4.2.4.1 Label Content Comparison of Five Currently Marketed Products -- 4.2.5 Misbranding -- 4.3 User Fees -- References -- Chapter 5: During and After Review -- 5.1 FDA Review of Your Device Application -- 5.1.1 FDA Review Process -- 5.1.1.1 Additional Information Letter (Deficiencies Noted During Review) -- 5.1.2 510(k) Review Process.

5.1.3 PMA Review Process -- 5.1.3.1 Summary of Safety and Effectiveness Data (SSED) -- 5.1.4 De Novo Review Process -- 5.1.5 Combination Products -- 5.2 Advertising and Promoting Your Device -- 5.3 Post-Marketing Requirements -- 5.3.1 Post-Market Safety Monitoring and Reporting -- 5.3.1.1 Mandatory Medical Device Reporting (MDR) -- 5.3.1.2 Voluntary Medical Device Adverse Event Reporting -- 5.3.1.3 MedSun -- 5.3.2 Post-Marketing Study Requirements -- 5.3.3 The Future of Post-Marketing Safety Surveillance -- 5.3.4 Periodic (Annual) Reports -- 5.3.5 Medical Device and Establishment Registration -- 5.3.6 Medical Device Tracking -- 5.3.7 Record Keeping Requirements -- 5.4 Product Updates -- 5.4.1 Updates to 510(k)s -- 5.4.1.1 Determining Impact to Safety and Effectiveness of the Device -- 5.4.2 Updates to PMAs -- 5.5 Recalls, Corrections, and Removal of Devices -- 5.5.1 Voluntary Device Recall -- 5.5.2 Mandatory Device Recalls -- 5.5.3 Device Corrections and Removals -- References -- Part II: Overview of Intellectual Property Rights for Medical Device Technology -- Chapter 6: Patents -- 6.1 Patent Protection as an Intellectual Property Strategy for Medical Device Technology -- 6.1.1 Research Agreements -- 6.1.2 Making an Invention Disclosure Statement to Your Patent Attorney -- 6.2 Patentability Requirements in the United States -- 6.2.1 Patentable Subject Matter -- 6.2.2 Invention Has Utility -- 6.2.3 Invention Is Novel -- 6.2.4 Invention Is Non-Obvious -- 6.3 Public Disclosures -- 6.4 Provisional Applications -- 6.5 Non-Provisional Applications -- 6.5.1 The Anatomy of a Patent Application -- 6.5.1.1 Claims -- 6.5.1.2 Specification -- 6.5.2 The "Duty to Disclose" -- 6.5.3 Assignment of Patent Rights -- 6.5.4 Inventorship vs. Ownership -- 6.5.4.1 Inventorship -- 6.5.4.2 Ownership -- 6.5.5 What to Expect: The Patent Application Examination Process.

6.5.6 Continuing Applications -- 6.6 Going Global: International Patent Considerations -- 6.6.1 Patent Cooperation Treaty (PCT) -- 6.7 Clearly Defining Over Crowded Prior Art -- 6.7.1 Avoiding Design-Arounds with Broad Claims -- 6.8 Unique Patent Challenges for Medical Devices -- 6.8.1 Medical Device Claims vs. Medical Device Use Claims -- 6.8.2 Diagnostic Methods -- 6.8.3 Methods of Treatment -- 6.8.4 Medical Device Software -- 6.9 Getting Patent Term Extension for Medical Devices -- 6.10 Post Allowance Challenges -- 6.10.1 Post Grant Review -- 6.10.2 Inter Partes Review (IPR) -- 6.10.3 Ex Parte Reexamination -- References -- Chapter 7: Trademarks -- 7.1 Trademarks in Medical Device Technology -- 7.2 What Is a Trademark? -- 7.3 Non-Protectable Subject Matter -- 7.4 Selecting a Trademark -- 7.4.1 Brainstorming Phase -- 7.4.2 Narrowing Phase -- 7.4.3 Knockout Phase -- 7.4.4 Clearance Search -- 7.4.5 Obtaining a Legal Opinion -- 7.5 Protecting a Trademark -- 7.5.1 Common Law of Trademark -- 7.5.2 Federal Trademark Protection -- 7.5.2.1 The Federal Trademark Application Requirements -- 7.5.2.2 Examination -- 7.5.3 State Registration -- 7.5.4 International Protection -- 7.5.4.1 Madrid Protocol -- 7.5.4.2 European Union Trademark -- 7.6 Maintaining Trademark Rights -- 7.6.1 Maintaining Federal Registration -- 7.6.2 Licensing Trademarks -- 7.6.3 Assignment of Trademarks -- 7.6.4 Policing Trademark Use -- 7.6.4.1 Genericide -- References -- Chapter 8: Trade Secrets -- 8.1 Secrecy Creates Value: How Medical Device Innovators Utilize Trade Secret Protection -- 8.2 What Are Trade Secrets? -- 8.3 Independent Discovery and Reverse Engineering of Trade Secrets -- 8.4 Theft of Trade Secrets: Misappropriation -- 8.4.1 Defense of Trade Secrets Act -- 8.4.2 Corporate Espionage -- 8.4.3 Employee Poaching -- 8.4.4 Cyber Theft -- References.

Chapter 9: Copyrights in Medical Device Technology -- 9.1 Copyrightable Subject Matter in Medical Technology -- 9.2 Scope of Protection -- 9.2.1 Software and Apps as Copyrightable Matter -- 9.2.2 Advertising, Marketing Materials and Product Packaging -- 9.2.3 Training Manuals, User Manuals and the Like -- 9.2.4 Trade Secrets and Other Materials Including Software -- 9.2.5 Data and Databases -- 9.3 Ownership and Authorship -- 9.3.1 Works for Hire -- 9.3.2 Jointly Authored Works -- 9.4 Licensing and Assignment of Copyrights -- 9.5 Derivative Works -- 9.6 Fair Use -- 9.7 Registration Issues -- 9.8 International Copyright Protection -- 9.8.1 The Berne Convention for the Protection of Literary and Artistic Works -- 9.8.2 Universal Copyright Convention -- References -- Chapter 10: Design Protection for Medical Devices -- 10.1 Design Patents for Medical Devices -- 10.1.1 Requirements for Design Patents -- 10.1.2 Protection Afforded by Design Patents -- 10.1.2.1 Priority Claims for Design Patents -- 10.1.3 Design Patent Disputes -- 10.1.3.1 Apple v. Samsung -- 10.2 International Design Protection -- 10.2.1 Design Protection in Europe -- 10.2.2 Design Protection in Asian Countries -- 10.2.3 The Hague Agreement -- 10.3 Importance of Protecting Medical Device Designs -- 10.3.1 Graphical User Interfaces and Icon Designs -- 10.3.2 Replacement/Consumable Parts -- References -- Chapter 11: Intellectual Property Issues in Medical Device Labeling and Marketing -- 11.1 Government Controls Over Medical Device Advertisements and Labeling -- 11.1.1 Food and Drug Administration -- 11.1.2 Federal Trade Commission -- 11.1.3 State Regulation -- 11.1.4 Government Controls Abroad -- 11.1.5 Patent Marking -- 11.2 Non-Government Controls -- 11.3 Comparative Advertising -- References -- Chapter 12: Enforcement, Infringement and Monetization of Intellectual Property Rights.

12.1 Policing Your IP Rights.

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