FDA finalizes guidance on approval of IVDs during public health emergencies

Original from: Regulatory Affairs Professionals Society

The US Food and Drug Administration (FDA) issued finalized guidance on Monday outlining the criteria for authorizing emergency use of unapproved in vitro diagnostic tests (IVDs) during future public health emergencies.

This guidance establishes a formal policy for how the FDA will exercise enforcement discretion during a public health emergency. It notes that in May 2022, the US Government Accountability Office (GAO) recommended that the FDA develop a permanent policy for exercising enforcement discretion in future public health emergencies in a report to Congress.

“Under section 564 of the FD&C Act, FDA may authorize emergency use of unapproved medical products, or unapproved uses of approved medical products, when certain criteria are met, after the HHS Secretary has made a relevant declaration of emergency or threat justifying authorization of emergency use, to diagnose, treat, or prevent diseases or conditions caused by CBRN [chemical, biological, radiological, and nuclear] threat agents, as well as other agents that may present a heightened risk to the U.S. military forces,” FDA wrote in the final guidance.

The agency indicated that when determining whether to allow the use of unapproved tests, it would consider several factors: the public health need, the potential benefits and risks associated with these tests, the availability of alternative options, and the ability to manage the risks of inaccurate test results.

FDA stated that it will assess testing requirements within the framework of the emergency response. This evaluation may consider the number of FDA-approved in vitro diagnostics (IVDs), access to these IVDs, and whether there is adequate time to wait for an IVD to receive emergency use approval.

The agency also plans to evaluate both the potential benefits and risks to public health associated with the use of unapproved IVDs. The benefits may include timely clinical management of patients and effective infection control. However, the risks could involve severe consequences from life-threatening diseases or conditions, the complexity of IVD technology, and the impact that false results could have on patient care.

FDA will also assess the extent to which there are alternative approved or authorized IVDs available.

Lastly, the agency will consider factors that could reduce the risk of false results from unapproved or unauthorized IVDs. The guidance states that “false results not only negatively impact the individual patient relying on an in vitro diagnostic test but can also have an impact on broad public health decisions during an emergency.”

The guidance replaces an earlier draft guidance that was issued on 6 May 2024. The guidance clarifies that the scope of the guidance includes IVD tests, according to a Federal Register notice.

Source: FDA finalizes guidance on approval of IVDs during public health emergencies