NEW YORK – The US Food and Drug Administration on Monday issued a draft guidance on the validation of in vitro diagnostic devices for the detection of emerging pathogens during a declared emergency.
Agency officials said that the finalized guidance will provide recommendations for test data and information that is submitted in support of an Emergency Use Authorization, pre-EUA request, or test that is offered under an enforcement discretion policy. The guidance is applicable during a public health emergency declaration and is meant to provide clarification on the agency's standards for the information to support tests that are intended for the detection of newly identified, previously unknown, or unusual pathogens or a known pathogen that aids the diagnosis of a newly identified or unusual clinical presentation.
The FDA said in a Federal Register notice that the draft guidance and an associated template for EUA submissions are intended to address two independent assessments of the agency's response to COVID-19. A 2021 report from Booz Allen Hamilton included recommendations that the FDA develop a framework for how to validate tests during a public health emergency, and a 2022 Inspector General's report recommended that the agency develop a suite of EUA templates for future emergencies as well as expand and improve its resources on the EUA process.
The draft guidance states that the validation of a test should demonstrate consistent performance by a finished device, and the agency recommends that validation testing is performed under the defined conditions for the final test design. Test kits should undergo validation testing on initial production units, lots, batches, or equivalents.
The document includes a table for the recommended types of validation studies or situational recommendations for lab-based, home sample collection, point-of-care, and home-use tests. It also contains recommendations on the evaluation of test accuracy, details about the agency's expectations for clinical performance evaluation, and considerations specific to certain types of tests.
The FDA is accepting comments on its draft guidance until March 7.