FDA Proposes Reclassification of Companion Diagnostic Tests

Original from: 360dx

The US Food and Drug Administration on Tuesday released a proposal to reclassify companion diagnostic assays from Class III medical devices to Class II devices.

In its proposal in the Federal Register, the agency said that it would reclassify certain Class III nucleic acid-based tests indicated for use with a corresponding approved oncology therapeutic product from Class III into Class II devices, subject to premarket notification.

Class II devices are subject to 510(k) approval, while Class III devices require premarket approval.

According to the agency, Class II devices are devices 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. Those special controls include issuance of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, and recommendations.

The proposal includes in vitro diagnostic devices intended to detect specific genetic variants and/or other nucleic acid biomarkers in human clinical specimens using nucleic acid amplification technology and/or sequencing technology that are indicated for use with a corresponding approved oncology therapeutic product.

"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 FDA wrote.

According to the agency, the order, if finalized, will decrease regulatory burden on industry because manufacturers will go through the less burdensome and "generally more cost-effective" 510(k) pathway.

"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 FDA wrote. "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 comment period on the proposal is open until Jan. 26, 2026.

In a blog post, healthcare consultant Bruce Quinn noted that the proposal would change "the landscape of how hard it is to get an FDA label as a companion diagnostic." The change would also have implications for Medicare reimbursement, he said.

Source: FDA Proposes Reclassification of Companion Diagnostic Tests