Hematology and Pathology Devices; Reclassification of Immunohistochemistry Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product

Official abstract: The Food and Drug Administration (FDA) is proposing to reclassify immunohistochemistry (IHC) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes MVC, NKF, QQT, NQF, PLS, PKW, QUL, QNH, QZJ, SBL, SER, and SHF), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is proposing minor revisions to an existing classification regulation and 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.