If finalized, FDA’s proposed classification would reduce the requirement for individuals seeking clearance for oncology companion diagnostics from a premarket authorization to a 510(k) premarket notification

On November 25, 2025, the U.S. Food and Drug Administration (FDA) issued a proposed order to reclassify nucleic acid-based test systems indicated for use with an approved oncology therapeutic product (product codes OWD, PJG, PQP and SFL) from the more stringent class III device classification to a class II classification.[1] This change would lessen the administrative burden to obtain device clearance and lower the research and development costs associated with such test systems.

Under Section 513(f)(3) of the federal Food Drug and Cosmetic Act (FDCA), FDA can reclassify a class III device by administrative order into a class I or class II device. To do so, the proposed new class must have sufficient regulatory controls to provide “reasonable assurance of the [device’s] safety and effectiveness” for its intended use.[2]

A class III device is higher risk than a class II device either because there is insufficient information to determine that FDA’s general controls (such as premarket registration) will ensure safety and effectiveness or, by example, because the device supports or sustains human life. A class II device is sufficiently safe and effective with special controls such as postmarket surveillance and patient registries.

Oncology molecular companion diagnostics are currently class III devices that require a premarket authorization (PMA) prior to commercial distribution—an approval process that requires more clinical support than the 510(k) premarket notification and clearance pathway for a class II product. For example, as of FDA’s proposed rule, FDA has approved original PMAs for relevant test systems including the Idylla CDx MSI Test, BRACAnalysis CDx, cobas 4800 BRAF V600 Mutation Test and FoundationFocus CDxBRCA Assay.

FDA stated that its review of existing PMA data, peer-reviewed data and postmarket adverse event reporting led it to find that per Section 513(a)(1)(B) of the FDCA, there is sufficient information to establish special controls, which would ensure safety and effectiveness in conjunction with general controls.[3] If finalized, FDA’s proposed classification would reduce the requirement for individuals seeking clearance for oncology companion diagnostics from a premarket authorization to a 510(k) premarket notification.[4]

In its proposed rule, FDA outlines special controls and a class II classification identifying such testing systems as prescription in vitro diagnostic (IVD) devices intended to detect specific genetic variant(s) and/or other nucleic acid biomarkers in human clinical specimens using nucleic acid amplification technology (such as PCR) and/or sequencing technology (such as next generation sequencing technology), and indicated for use with a corresponding approved oncology therapeutic product.[5] FDA includes in this classification test systems that include IVD CDx devices, which are “essential to the safe and effective use” of the corresponding product.[6] The classification also includes IVD test systems that are not essential for the safe and effective use of a corresponding product, but are referenced in that product’s labeling and provide risk/benefit information about patient populations using the corresponding product.[7]

FDA’s proposed special controls for the new classification include[8]:

• Labeling requirements such as inclusion of relevant limitations with respect to genomic regions that cannot be targeted and a description of analysis algorithms used for biomarker detection and annotation, evaluation and classification, as well as a description of the quality metrics, thresholds and filters utilized at each step of the test; and
• Design verification and validation such as specification for risk mitigation elements to address risks of false positive or negatives and failure to properly interpret results.

Relevant test systems will also need to meet prescription labeling requirements for IVD products under 21 C.F.R. § 809.10(a)(4) and (b)(5)(iii).[9] If the proposed regulation requiring a description of analysis algorithms and quality metrics is adopted, it may restrict the ability to maintain such information as a trade secret.

The comment period for this rule is open until January 26, 2026.

For More Information 

If you have any questions about this Alert, please contact Vicki G. Norton, Ph.D., Victoria (Tori) Hawekotte, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.

Notes

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