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FDA Seeks More Data in Cue Health De Novo Request for RSV Molecular Test

NEW YORK – Cue Health announced in documents filed with the US Securities and Exchange Commission on Tuesday that the US Food and Drug Administration has denied its request for de novo authorization of its respiratory syncytial virus molecular test for over-the-counter use. 

Cue said that the FDA has determined that the RSV test does not meet the criteria under the Federal Food, Drug, and Cosmetic Act to be classified as a Class I or Class II medical device for the proposed over-the-counter indications for use. Based on review of the de novo request, the FDA was not able to determine that the benefits of the device outweigh the risks for the indicated use and requested more data from the company. 

A Class I device is defined by the FDA as a device that presents minimal potential for harm to the user. Most medical devices are considered Class II devices, the FDA noted. 

The San Diego-based firm said in the SEC filing that it is "continuing active dialogue with FDA to understand how best to address its concerns." Cue then plans to resubmit a request for either de novo or 510(k) approval for its RSV test, it added.