Greenleaf Health was invited by a partner at a prominent D.C. law firm to write a chapter on in vitro diagnostics (IVDs) for inclusion in a book to be published by the Food and Drug Law Institute (FDLI). In vitro diagnostics have become an increasingly large part of Greenleaf’s portfolio of regulatory services, furthered by the FDA’s issuance of Emergency Use Authorizations (EUAs) for IVDs intended to detect and/or diagnose the virus that causes COVID-19. The mandate for this book chapter was to discuss the challenges of regulating IVDs as medical devices and the evolution of IVD regulation within the broader regulatory framework for devices over the last 40 years. 

The makeup and experience of the Greenleaf Medical Device and Combination Products Team allowed us to approach this assignment from various points of view and direct involvement in the history of medical device regulation at the FDA’s Center for Devices and Radiological Health. Greenleaf used this opportunity to share the company’s expertise in the IVD space with the wider audience drawn by the FDLI and provide a useful perspective on this timely policy issue for potential readers.