All in vitro diagnostics (IVDs) for human use are medical devices. After that, it is easy to get lost in a seemingly foreign language of acronyms—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? How does it even begin to know into which category its new device will fall? The US Food and Drug Administration (FDA) has several good guidance doc...