FDA and Intellectual Property Strategies for Medical Device Technologies : Including Artificial Intelligence, Software and Applications / / by Gerald B. Halt, Jr., John C. Donch, Jr., Amber R. Stiles, Brandon R. Theiss, Michelle Byrne, William F. Hodnick, Joshua Eldridge, Randy Goodman, Lisa Jenkins VanLuvanee, Dana L. Blue

• Autore: Halt Jr., Gerald B
• Pubblicazione: Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2026
• Edizione: 2nd ed. 2026.
• Descrizione fisica: 1 online resource (472 pages)
• Disciplina: 610.28
• Soggetto topico: Biomedical engineering; Electronics; Microtechnology; Microelectromechanical systems; Biomedical Engineering and Bioengineering; Electronics and Microelectronics, Instrumentation; Microsystems and MEMS
• Nota di contenuto: Introduction -- Development of A New Medical Device -- Determining If A Medical Device Technology Is FDA Regulated -- Basic FDA Regulatory Requirements For Medical Devices -- Other Regulatory Consideration For Medical Devices -- Benefits of Having FDA Approval -- Patents -- Trademarks and Trade Dress -- Trade Secrets -- Copyrights In Medical Device Technology -- Design Protection For Medical Devices -- Intellectual Property Issues in Medical Device Labeling and Marketing -- Enforcement, Infringement and Monetization of Intellectual Property Rights -- Successful Implementation of a Medical Device Company’s IP Strategy -- Tips for Avoiding and Preventing Intellectual Property Problems -- Successful Implementation of a Medical Device Company’s Regulatory Strategy -- Tips for Avoiding and Preventing Regulatory Problems -- Potential Combined IP and Regulatory Pitfalls.
• Sommario/riassunto: This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States Food and Drug Administration (US FDA) regulatory review and approval/grant/clearance process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review and approval/grant/clearance process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA, 510(k), and De Novo application processes. The complexities of medical device commercialization in the US market are also discussed. Additionally, this book explores how Artificial Intelligence (AI) and new software innovations are impacting the medical regulatory space. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies, and scenarios to illustrate the topics discussed and is intended for use by medical device designers, developers, and innovators. Investigates the US FDA medical device approval/grant/clearance process and commercialization of these products in the US market; Addresses some of the major FDA hurdles that medical device innovators often face while seeking approval/grant/clearance; Discusses the interplay between FDA regulatory review of medical device technology and intellectual property strategy.
• Titolo autorizzato: FDA and Intellectual Property Strategies for Medical Device Technologies
• ISBN: 3-032-12649-5
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9911057021603321
• Lo trovi qui: Univ. Federico II
• Serie: Engineering Series