Last week, the U.S. Food and Drug Administration (FDA) issued a final order classifying in vitro diagnostic (IVD) tests that utilize next generation sequencing (NGS) to profile cancer tumors into Class II (special controls). In the order, FDA named the generic type of device “Next Generation Sequencing Based Tumor Profiling Test” and described it as a qualitative IVD test “intended for NGS analysis of tissue specimens from malignant solid neoplasms to detect somatic mutations in a broad panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals.” FDA, Final Order, Medical Devices; Immunology and Microbiology Devices; Classification of the Next Generation Sequencing Based Tumor Profiling Test, 83 Fed. Reg. 28,994, 28,994-95 (June 22, 2018). FDA codified the classification at 21 C.F.R. § 866.6080.

The practical effect of FDA’s De Novo classification order is that the specific device that was classified—the MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) test developed by Memorial Sloan-Kettering Cancer Center’s Department of Pathology—now can serve as a predicate for future devices of the same type, including for premarket notification submissions under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). See 21 U.S.C. § 360c(f)(2)(B)(i). As a result, other developers of similar NGS-based IVD tests will not have to submit a De Novo classification request or premarket approval (PMA) application in order to market a substantially equivalent device. See id. § 360c(i) (defining ‘‘substantial equivalence’’). Instead, such device sponsors can use the less-burdensome 510(k) process to market their device.