Eric Konnick, MD, MS, FCAP, and Jonathan R. Genzen, MD, PhD, FCAP discuss the FDA’s proposed rule on laboratory-developed tests to be classified as medical devices under the Federal Food, Drug, and Cosmetic Act. “Under the current regulations, licensed and certified laboratory professionals, including physician pathologists, are allowed to modify or create new tests so long as they follow the requirements in the current regulations and validate the assays before being clinically offered,” said Dr. Konnick.
For the full article click here: Proposed Rule on Laboratory-Developed Tests Would Negatively Affect Cancer Care and Innovation, Critics Say