PHOENIXVILLE, PA — Facet Life Sciences has released the second edition of “FDA and Intellectual Property Strategies for Medical Device Technologies,” an updated guide for medical device developers, the company announced.
The book, published by Springer International Publishing, addresses regulatory requirements and intellectual property considerations for medical device technologies and is available online at link.springer.com.
According to the company, the second edition updates regulations and guidance related to U.S. Food and Drug Administration medical device approval, clearance and commercialization. It also provides examples of regulatory challenges and examines the relationship between FDA review and intellectual property strategy.
Six Facet Life Sciences employees contributed to the publication: Michelle Byrne, William Hodnick, Joshua Eldridge, Randy Goodman, Lisa Jenkins VanLuvanee and Dana Blue.
Lisa Jenkins VanLuvanee, the company’s chief operating officer and vice president of research and development, said the updated edition reflects changes in technology and the regulatory environment affecting medical device development.
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