FDA Draft Guidance Aims to Expand Testing Options During Health Emergencies

In response to calls from the laboratory-developed test (LDT) industry and infectious disease clinicians, the US Food and Drug Administration (FDA) recently issued draft guidance aimed at expanding enforcement discretion during public health emergencies and emerging health threats. According to an article by Regulatory Focus, the FDA draft guidance is part of broader efforts to encourage the development of more diagnostic testing options.

One draft guidance outlines the FDA’s enforcement policy for laboratory manufacturers offering unauthorized in vitro diagnostic devices (IVDs) in immediate response to chemical, biological, radiological, or nuclear (CBRN) threats outside of declared emergencies. This move comes as the FDA phases out its general enforcement discretion for LDTs under a controversial final rule treating all IVDs as medical devices.

Meanwhile, another draft guidance details when the FDA may apply enforcement discretion for tests developed during declared public health emergencies. Stakeholders, including the American Clinical Laboratory Association (ACLA), have expressed concerns about the FDA’s regulatory approach, arguing it could hinder timely test development and availability. ACLA urged the FDA to clarify and expand the scope of the immediate response guidance to include more laboratories and testing scenarios.

Other organizations, such as AdvaMedDx and the Association of Public Health Laboratories (APHL), have called for broader inclusivity in FDA’s guidance, advocating for policies that consider the expertise and capacity of all IVD manufacturers, not just specific types. APHL emphasized the importance of consulting public health labs and CDC during policy development to ensure an effective response to regional health threats.

The draft guidance also drew recommendations from the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM), focusing on regional considerations and broader factors like specimen types and test performance during emergencies.

Overall, while the FDA draft guidance aims to streamline emergency responses and foster innovation in diagnostic testing, the article suggests that stakeholders continue to debate the regulatory balance between safety, accessibility, and rapid deployment of reliable tests during health crises.