The U.S. Food and Drug Administration (FDA) has released a draft guidance giving recommendations for validating in vitro diagnostic devices (IVDs) for emerging pathogens during a declared emergency.
The FDA noted that the draft guidance was informed by recommendations it received from two independent assessments of the agency’s response to the COVID-19 pandemic.
In its announcement, the FDA notes that the guidance covers diagnostic tests “intended to detect a newly identified, previously unknown, or unusual pathogen(s) to aid in the diagnosis of a serious or life-threatening infectious disease or condition; or to detect a known pathogen(s) that aids in diagnosing a newly identified or unusual clinical presentation of such a disease or condition.”
The agency said that the recommendations apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered under an applicable enforcement discretion policy during a declaration of emergency under section 564 of the Federal Food, Drug, and Cosmetic Act. Furthermore, the recommendations cover all stages of an outbreak and include a discussion about appropriate validation depending on the stage of the outbreak, the FDA said.
The FDA is also making a generic template available for download on its site that reflects the agency’s current thinking on validation study recommendations. Comments may be submitted on the draft guidance until March 7, 2025.
