Of Counsel Benjamin Zegarelli spoke with MD+DI on the FDA’s updated regulations to classifying laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Benjamin said, “Many LDT developers will become subject to FDA regulations that are already applicable to other medical devices, including other in vitro diagnostic devices, such as requirements to register manufacturing facilities and list commercial devices with FDA, applying compliant labeling to commercial devices, reporting certain device adverse events and malfunctions, and implementing a compliant quality system.”

Source

MD+DI