Volpe Koenig Announces Second Edition of FDA and IP Strategies for Medical Devices Book

FDA and Intellectual Property Strategies for Medical Device Technologies is now available in its second edition, which expands on prior guidance of the FDA regulatory review process and intellectual property concerns for U.S. medical device innovators.

The updated edition includes new discussion on the complexities of commercializing medical device technologies and the impact of AI and other software innovations on the medical regulatory space.

Volpe Koenig co-authors Gerald (“Jay”) B. Halt, Jr., John C. Donch, Jr., along with former Volpe Koenig patent professionals Brandon R. Theiss and Amber R. Stiles, introduce the intellectual property rights available for medical device inventions and explore ways to overcome the unique intellectual property challenges innovators face.

Facet Life Sciences co-authors Michelle Byrne, William F. Hodnick, Joshua Eldridge, Randy Goodman, Lisa Jenkins VanLuvanee, Ph.D. and Dana Blue, M.S. discuss strategies for navigating the FDA regulatory review and approval/grant/clearance process, as well as provide guidance on the PMA, 510(k) and De Novo application processes.

The book’s authors have extensive collective experience in law and research and development.

The second edition is available online and in hardcover from Springer International Publishing and in both Kindle and hardcover formats on Amazon.