FDA Places Circulating Tumor Cell Enrichment Devices in Class II

The Food and Drug Administration has officially placed a specific type of medical tool, called a circulating tumor cell enrichment device, into Class II of its regulatory system. This classification was finalized on May 24, 2022, after the agency reviewed a request from ANGLE Europe Ltd. for its Parsortix PC1 device.

Why it matters: The practical effect is mostly administrative and procedural. It removes a regulatory roadblock for one specific device and sets a precedent that lowers the paperwork and testing burden for future competitors making the same type of blood-testing tool. Patients and clinicians may eventually see more options for this test, but the immediate impact is a shift in how manufacturers navigate FDA rules.

Who it affects

• Manufacturers of in vitro diagnostic devices that isolate circulating tumor cells from blood

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This final order was issued by the Food and Drug Administration and published in the Federal Register; readers relying on the regulatory details should consult the original document before making compliance or business decisions.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document