Cue Health Inc. announced that it received a response letter from the U.S. Food and Drug Administration (FDA) on April 3, 2024 regarding its De Novo request to classify its respiratory syncytial virus (RSV) molecular test for over-the-counter use as class I or class II under the Federal Food, Drug and Cosmetic Act (the FD&C Act). The letter indicates that the FDA has determined that after review of the information submitted in the request that the Cue RSV molecular test does not meet the criteria under the FD&C Act for classification into class I or class II for the proposed Over-The-Counter (OTC) indications of use. The letter states that based on review of the De Novo request thus far, FDA is not able to determine that the benefits of the device outweigh the risks for the indicated use, and requests further data to support a favorable benefit-risk profile in the OTC intended use setting.

The Company is continuing active dialogue with FDA to understand how best to address its concerns. Based on this dialogue, The Company then plans to expediently address all of FDA?s concerns through a re-submission either through a DeNovo or traditional 510(k) pathway.