Cancer Tests Downgraded to Class II: FDA's Device Shuffle
Published Date: 8/17/2026
Rule
Summary
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.
Analyzed Economic Effects
5 provisions identified: 3 benefits, 1 costs, 1 mixed.
Manufacturers: PMA → 510(k) Pathway
If you make in situ hybridization (ISH) tests indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), those devices are reclassified from class III to class II effective September 16, 2026. After that date, manufacturers may submit a 510(k) premarket notification instead of a premarket approval (PMA) to market these devices, which typically shortens the review timeline.
Patients: Faster Access to ISH Tests
You may get access to more oncology in situ hybridization (ISH) tests sooner because manufacturers can seek 510(k) clearance instead of PMA after September 16, 2026. FDA expects this reclassification will enable more manufacturers to develop and market these tests, increasing availability for clinicians and patients.
Existing PMA Devices Can Continue Marketing
Oncology therapeutic ISH-based test systems that had prior PMA approval and were legally marketed before September 16, 2026 may continue to be marketed under their existing PMA. If a manufacturer makes a change that could significantly affect safety or effectiveness or a major change in intended use, FDA expects a 510(k) submission per Sec. 807.81(a)(3).
Validation Rules: Surrogate Samples Allowed; Stability Removed
FDA revised the special controls: FDA will consider surrogate samples that adequately represent intended-use specimen types and biomarkers to supplement clinical specimens for precision/reproducibility studies (as determined by FDA). FDA also removed the previously proposed special control that would have required device performance data demonstrating reagent stability.
510(k) Premarket Notification Still Required
FDA did not exempt oncology therapeutic ISH-based test systems from 510(k) requirements under section 510(m); therefore, persons who intend to market these class II devices must submit a 510(k) and obtain FDA clearance before marketing. These tests are prescription in vitro diagnostic (IVD) devices and must meet IVD labeling requirements under Sec. 809.10.
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