Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests

Hogan Lovells US LLP, representing clients, opposes the proposed reclassification of Mycobacterium tuberculosis tests from class III to class II devices. They argue that the reclassification would eliminate critical premarket oversight of manufacturing processes and environmental controls, potentially compromising test reliability and safety.

Revvity Health Sciences Inc. supports the proposed reclassification of IGRA devices from Class III to Class II, provided that the FDA implements robust special controls. They argue that because there is no microbiological gold standard for these tests, the FDA must require independent clinical performance data and clear validation expectations to ensure diagnostic reliability and public health safety.

An individual working in the development of in vitro diagnostics (IVDs) supports the reclassification of Tuberculosis tests from Class III to Class II. They argue that the current Class III requirements are too costly and that a Class II designation will better encourage industry innovation to meet the growing need for TB testing.

Danaher Diagnostics (specifically its subsidiary Cepheid) supports the FDA's proposal to reclassify Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests from Class III to Class II. They argue this will reduce regulatory burdens and encourage innovation, while also recommending the inclusion of host transcriptional gene tests in the reclassification scope.