While receiving less public attention than some other types of health care products, in vitro diagnostics (IVDs) have for years been playing an increasingly important role in health care. The COVID-19 pandemic has highlighted what has long been the case: IVDs are indispensable to public health. Whether used as companion diagnostics to guide therapeutic treatment, or liquid biopsy to identify tumors from blood tests, or to detect an infectious disease, or to help determine whether a patient has had a heart attack, or in thousands of other ways, IVDs are essential in medicine.
There has not, however, been a single source that someone could consult to learn about how IVDs are regulated today. To fill that void, the Food and Drug Law Institute (FDLI) has just released Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment, the first book in over a decade that addresses the world of IVD regulation.
The book comprehensively covers diagnostic regulatory issues, from premarket issues, e.g., analytical testing, statistics, clinical studies, and pathways to the market, to post-market issues, such as Quality System Regulation and Medical Device Reporting. And, of course, it addresses two of our favorite topics: laboratory developed tests (LDTs) (see, e.g., our earlier posts here, here, here, here, here, and here) and research use only (RUO) products. The authors represent a range of disciplines and expertise. To name just a few, they include Dan Schultz, former director of CRRH; Nina El-Badry of BARDA; and Sally Hojvat, who was Director of one of the IVD Divisions at CDRH and now consults with WHO; and several colleagues at Hyman, Phelps & McNamara, P.C., and other law firms. The book also covers other topics critical to IVD manufacturers and investors, such as reimbursement – simply getting on the market isn’t often enough for a test to be commercially viable – and the evolving European regulatory model.
More information about the book can be found here: https://www.fdli.org/IVD-book.
With the ongoing leaps in technology the importance of IVDs will only continue to grow. We expect that this book will be a valuable resource for those who are seeking to learn how to better understand and navigate the world of IVD regulation.