Dispositivi di ematica e patologia; riclassificazione o sistemi di test di ibridazione in situ per l'uso con un prodotto terapeutico oncologico corrispondente approvato

Riepilogo

La Food and Drug Administration (FDA, the Agency, or we) sta emettendo un ordine finale reclassificando in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all post-amendments class III (premarket approval) devices, into class II (special controls), subject to premarket notification. FDA sta anche istituendo una nuova device classification regulation, alongside the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of this device type.