FDA and intellectual property strategies for medical device technologies. (2019)

• Record Type: Book
• Further Information: Note: Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss and Dana L. Blue.
• Authors: Jr, Halt, Gerald B; Jr, Donch, John C; Stiles, Amber R; VanLuvanee, Lisa Jenkins; Theiss, Brandon R; Blue, Dana L
• 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) Application2.4.3.2 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 Meetings3.1.5.5 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)
• Publisher Details: Cham : Springer
• Publication Date: 2019
• Extent: 1 online resource
• Subjects: 610.28; Medical technology; Pharmaceutical policy; Intellectual property; International trade; Drug accessibility; HEALTH & FITNESS / Holism; HEALTH & FITNESS / Reference; MEDICAL / Alternative Medicine; MEDICAL / Atlases; MEDICAL / Essays; MEDICAL / Family & General Practice; MEDICAL / Holistic Medicine; MEDICAL / Osteopathy; Electronic books; Electronic books
• Languages: English
• ISBNs: 9783030044626; 3030044629
• Related ISBNs: 9783030044619
• Notes: Note: Includes bibliographical references and index.; Note: Online resource; title from PDF title page (EBSCO, viewed January 31, 2019)
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.