FDA moves certain cancer diagnostic tests to a lower regulatory tier
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The Food and Drug Administration has issued a final order reclassifying specific in situ hybridization (ISH) test systems. These tests are used to determine if a patient is eligible for certain approved cancer treatments.
Why it matters: This is a significant administrative shift for the companies that make these diagnostic tests. By moving them to Class II, the FDA is signaling that the existing special controls are sufficient to ensure the tests work correctly, removing the need for the more expensive and time-consuming full premarket approval process. For patients, this may mean faster access to updated versions of these tests, though the core safety standards remain high.
Who it affects
- Manufacturers of in situ hybridization test systems for oncology
This action is a final rule issued by the U.S. Department of Health and Human Services, Food and Drug Administration, published in the Federal Register; readers should consult the original document for specific product codes and compliance deadlines.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document