FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices

The final rule is consistent with the proposed rule in many respects. As in the proposed rule, the final rule states that LDTs generally will be subject to FDA’s existing regulatory framework for medical devices by making explicit that IVDs are devices under the FDCA, including when the manufacturer of the IVD is a laboratory. However, FDA substantially expanded its list of tests that will be eligible for some form of “grandfathering” (i.e., continued enforcement discretion), including LDTs currently on the market, LDTs that obtain New York State approval, and certain LDTs offered by integrated health systems for patients with unmet needs, with certain important limitations.

Source: https://www.jdsupra.com/legalnews/fda-issues-final-rule-regulating-many-7112158/