FDA Proposes Reclassifying Oncology Companion Diagnostics, Potentially Easing Approval Path and Expanding Patient Access
The agency says shifting certain companion diagnostic tests from Class III to Class II could reduce regulatory burden, shorten review timelines, and encourage more manufacturers to enter the market.
The US Food and Drug Administration (FDA) has released a proposal that could significantly alter the regulatory pathway for oncology companion diagnostics, aiming to reduce barriers to market entry while maintaining assurances of safety and effectiveness.
In a notice published Nov. 25 in the Federal Register, the FDA said it plans to reclassify certain companion diagnostic assays from Class III medical devices to Class II devices. The proposal applies to specific nucleic acid–based in vitro diagnostic tests that are indicated for use with a corresponding FDA-approved oncology therapeutic product.
Under the current framework, Class III devices require premarket approval (PMA), the
FDA’s most rigorous and resource-intensive review process. Class II devices, by contrast, are typically cleared through the 510(k) premarket notification pathway, which is generally faster and less costly for manufacturers.
FDA Cites Maturing Technologies and Robust Safety Data to Support Reclassification
According to the agency, Class II devices are those for which “general controls by themselves are insufficient,” but for which “there is sufficient information to establish special controls to provide assurance of safety and effectiveness.” These special controls can include performance standards, postmarket surveillance, patient registries, and the development of guidelines and recommendations.
The proposed reclassification would cover in vitro diagnostic devices intended to detect specific genetic variants or other nucleic acid biomarkers in human clinical specimens. These tests rely on nucleic acid amplification technologies and/or sequencing technologies and are specifically tied to approved cancer therapies.
“Based upon the extensive [premarket approval] data available to FDA … published peer-reviewed literature studying the longstanding and well-understood technologies, and data available to the agency demonstrating a lack of significant postmarket safety signals with oncology therapeutic nucleic acid-based test systems, FDA believes there is sufficient information to reclassify these devices from Class III (premarket approval) into Class II (special controls),” the agency wrote.
The FDA emphasized that the proposal reflects both the maturity of the underlying technologies and the agency’s experience overseeing these products once they are on the market. Many companion diagnostics have been used clinically for years, generating substantial performance and safety data.
Reduced Regulatory Burden Could Accelerate Market Entry and Patient Access
If finalized, the change could have meaningful implications for diagnostic developers and patients alike. The FDA said the reclassification would “decrease regulatory burden on industry” by allowing manufacturers to pursue the “less burdensome” and “generally more cost-effective” 510(k) pathway rather than PMA.
“A 510(k) typically results in a shorter premarket review timeline compared to a PMA, which ultimately may provide more timely access of these types of devices to patients,” the agency said. “FDA expects that the reclassification of these devices would enable more manufacturers to develop these types of devices such that patients would benefit from increased access to appropriately safe and effective tests.”
The proposal comes as demand continues to grow for precision oncology tools that match patients with targeted therapies based on genetic and molecular profiles.
Companion diagnostics are often essential for determining whether a patient is eligible for a specific cancer drug, making regulatory timelines a critical factor in how quickly new therapies can reach the clinic.
The FDA stressed that the proposal does not eliminate oversight, but rather shifts it to a framework the agency believes is more proportionate to the risk profile of these tests. Special controls would still apply, and manufacturers would remain responsible for demonstrating that their devices are safe, effective, and substantially equivalent to legally marketed products.
The agency is seeking public input before finalizing the order. Comments on the proposal will be accepted through Jan. 26, 2026, giving stakeholders across the diagnostics, pharmaceutical, and healthcare sectors an opportunity to weigh in on how the change could affect innovation, competition, and patient care.
If adopted, the reclassification could mark one of the most consequential regulatory shifts for oncology companion diagnostics in years, potentially accelerating development timelines while expanding access to precision testing for cancer patients.
—Janette Wider
