Comment from Hogan Lovells US, LLP

May 29, 2026 VIA SUBMISSION TO REGULATIONS.GOV Noel Gerald Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Ave., Bldg. 66, Rm. 3114 Silver Spring, MD 20993 RE:Docket No. FDA– 2026–N–2590 for “Microbiology Devices; Reclassification of Mycobacterium tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests.” Dear Mr. Gerald: On behalf of one or more Hogan Lovells US, LLP clients, we appreciate the opportunity to submit comments regarding the Food and Drug Administration’s (“FDA” or “the Agency”) proposed reclassification of Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection (product codes NCD and OJN, respectively), both of which are postamendments class III devices (premarket approval), into class II (special controls), subject to premarket notification. We further understand that FDA is also proposing a new device classification regulation along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. Hogan Lovells US LLP supports the Agency’s efforts in developing appropriate, measured and limited, rational, and reasonable regulations that protect public health and promote delivery of safe and effective diagnostic products, including in vitro diagnostic tests that aid in the diagnosis of Mycobacterium tuberculosis infection. The proposed rule’s requirements for monitoring and ensuring that such Mycobacterium tuberculosis infection tests generate clinically meaningful and readily interpretable results by focusing on the analytical risks associated risks of inaccurate results, including failure to correctly interpret the test results, the risk of false test results, and failure to correctly operate the device causing false results, are meaningful and relevant. We urge FDA, however, to ensure the proposed rule appropriately addresses requirements for controlled, validated, and demonstrated reliability of the manufacturing process for the reagents, components, and solutions used in this class and type of test, as well as the ongoing control of the manufacturing facility and environment. Because cell-mediated immunity tests and cell-mediated immunity-response monitoring tools require careful control and access to patient cells, and incubation of cells in the presence of reagents and markers susceptible to contamination, misidentification, and manufacturing-related deficiencies unidentifiable by and outside the control of the end users. Adequate control and oversight of the production of and control of the manufacturing environment where the cell-mediated immunity tests and reagents are produced is also essential, because variations in water, air cleanliness, materials and component supply, identification, and qualification, and the validity of the manufacturing process are sources of assay inaccuracy and barriers to its reliability. The reclassification proposed rule fails in all respects to consider these risks. In the same light, the proposed order would eliminate FDA’s premarket oversight over these critical manufacturing and validation controls. If reclassified as proposed, such manufacturing controls would only be subject to post-market oversight by FDA, reducing both the level of current control and eliminating a key feature by which end users of such tests currently are able to rely – premarket FDA review and approval of the reliability and control of the methods by which and the environments within which these products and their components are manufactured. Hogan Lovells accordingly urges FDA to continue to regulate Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection as class III medical devices subject to FDA premarket approval. *** We thank the Agency for its consideration of our comments. If you have any questions, please do not hesitate to contact us at the contact information below. Sincerely, Randy Prebula Partner randy.prebula@hoganlovells.com D +1 (202) 637-6548