FDA Proposes Guidance Document for In Vitro Companion Diagnostic Devices

Jul 18, 2011   

Last week, the U.S. Food and Drug Administration (FDA) announced the release of a guidance document for in vitro companion diagnostic devices. According to the FDA, companion diagnostics are “tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give.” These diagnostic tests enhance the effectiveness of targeted treatments because they help to determine whether a patient is a genetic fit for a particular therapy. The guidance document clarifies the definition of a companion diagnostic and also provides guidance on the agency’s proposed policy for reviewing in vitro diagnostics and corresponding targeted therapies. The FDA is seeking public input on the draft guidance for 60 days.

The release of this new guidance document marks a significant change in the way the FDA has regulated these types of technologies. In particular, the guidance document signals a shift in the FDA’s regulation of companion diagnostic devices from enforcement discretion to risk-based oversight. The FDA intends to use the same risk-based process it uses to regulate all other medical devices, where the device’s regulatory pathway is determined by the level of risk to patients based on the device’s intended use and any concerns pertaining to its safety and effectiveness. Diagnostic devices will require submission of a premarket approval (PMA) or 510(k) premarket notification.

The FDA suggests that manufacturers should engage the FDA in the early stages of developing their products. The Agency also recommends that manufacturers develop therapeutic products and companion devices contemporaneously to facilitate the acquisition and review of clinical performance and clinical significance data. The guidance document suggests that the FDA will only approve targeted treatments after the corresponding companion device has gained FDA approval or clearance. The FDA outlined two exceptions where it may approve a targeted therapy before a companion diagnostic is approved: 1) when the therapy is intended to treat a serious or life-threatening disease or 2) where a condition has no available or satisfactory treatment and the potential benefits outweigh the risk of not having a cleared or approved companion device. In those cases, the FDA may approve a targeted therapy and clear or approve the device at a later time.

The FDA’s proposed guidance document for in vitro companion diagnostic devices raises interesting questions about how the FDA will continue to regulate similar types of industries, such as laboratory-developed tests (LDTs), where the FDA currently exercises enforcement discretion. While it is unclear whether the FDA will make changes to other industries that utilize similar technologies, the proposed guidance for FDA regulation of a companion diagnostic may be an indication that the FDA is moving away from enforcement discretion and is shifting toward a preference for a risk-based regulatory scheme.

Fuerst Ittleman will continue to monitor the progress of the FDA’s regulation of therapeutic and diagnostic devices. For more information, please contact us at contact@fidjlaw.com.