The FDA released a draft guidance defining in vitro (IVD) companion diagnostic devices and explaining the review and approval standards for related products. Additionally, the guidance clarifies instances when IVD companion diagnostic devices or therapeutic products may be approved singularly, as well as labeling requirements.
An IVD companion diagnostic device provides information that is essential for safe and effective use of a corresponding therapeutic product, according to the FDA definition. The use of such a device can be critical to identify patients who are most likely to benefit from a medicine; patients who are likely to be at risk from using a particular medicine; or to monitor response to treatments in order for adjustments.
Under ideal circumstances, the FDA recommended early interaction with regulators, and stated that IVD companion diagnostic devices and their corresponding therapeutic products should be developed contemporaneously, with clinical performance and significance established using data. However, the FDA acknowledged instances when both cannot be developed in conjunction.
For novel therapeutic products, the FDA “will determine that the IVD companion diagnostic device is properly validated and meets the applicable standard for safety and effectiveness or for substantial equivalence for the use indicated in the therapeutic product’s labeling,” according to the guidance. “FDA does not believe it may approve a novel therapeutic device if the IVD companion diagnostic device is not approved or cleared for that indication.”
But there are exceptions.
The FDA may decide to approve a product without a corresponding IVD companion diagnostic device if it treats a serious or life-threatening condition, and the benefits heavily outweigh the risks. The same rule may apply for already approved therapeutic products that need updated labeling, despite the lack of a cleared IVD companion diagnostic device.
"These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability," said Jeffrey Shuren, MD, director of FDA's Center for Devices and Radiological Health. "It is the agency's goal to help stimulate early collaborations between drug and device makers so they can develop the best medical products for treating patients."
The FDA stated that the intent behind the guidance—which will be open to a 60-day public comment period—is to assist sponsors who are planning on developing devices that use an IVD, or IVD developers who plan to have their product used in conjunction with a therapeutic device. Click here to read the full guidance.