Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
Key claim: FDA is moving certain cancer-related in situ hybridization lab tests used with approved oncology drugs from the strictest premarket approval path to a lighter special-controls/510(k) path.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all postamendments class III (premarket approval) devices, into class II (special controls), subject to premarket notification. FDA is also establishing a new device classification regulation, along with the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of this device type.
Why this matters
Down-classifying companion-diagnostic ISH oncology tests from PMA to 510(k) lowers the regulatory barrier for manufacturers to bring these tests to market, which can affect how quickly patients and oncologists gain access to diagnostics needed to qualify for targeted cancer drugs. Because these tests gate use of approved oncology therapeutics, changes in the diagnostic pathway indirectly shape drug access and reimbursement decisions.