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# Shuren Addresses Firm’s Criticism as ‘Misinformation’
- URL: https://www.fdaweb.com/shuren-addresses-firms-criticism-as-misinformation/
- Published: 2023-03-09T12:00:00.000Z
- Updated: 2026-09-14T18:18:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153947

CDRH director **Jeff Shuren** has taken the unusual step of addressing a company’s criticism directed at his Center’s alleged delay in granting an emergency use authorization (EUA) as a “misinformation” correction under FDA commissioner **Robert Califf**’s [initiative](https://www.fda.gov/news-events/fda-voices/highlighting-major-issues-critical-fda-across-our-diverse-agency-after-one-year-back?ref=fdaweb.com) to curb half-truths and misinformation that “pose enormous dangers to the effectiveness of science and to public health.”

Late last month, the agency issued Lucira Health an EUA for the first over-the-counter at-home diagnostic test for detecting influenza A and B, and Covid-19 ([see earlier story](https://www.fdaweb.com/fda-grants-eua-for-first-otc-flu-covid-test/)). In the company’s [press release](https://ir.lucirahealth.com/news-releases/news-release-details/lucira-health-announces-fda-authorization-first-only-home?ref=fdaweb.com) about the authorization, it explained that the company had to file for bankruptcy protection shortly before FDA’s EUA notice due to the “protracted authorization cycle” that delayed the review action. Lucira further said that its test would have been “especially useful during the recent, severe respiratory season, and we had produced inventory for an anticipated autumn 2022 launch.”

Presumably in response to the criticism, Shuren issued a [statement](https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-statement-emergency-use-authorization-lucira-healths-covid-19-flu-home-test?ref=fdaweb.com) explaining that the EUA delay was caused by Lucira failing to submit the required number of clinical samples and to FDA’s determination that one of the test’s components contained a toxic substance, “making it unsuitable for at-home use.” Shuren said that in late 2022 the company redesigned the test to address the problem and additional samples were included to address CDRH’s concerns.

In a recent [Twitter post](https://twitter.com/JWaldeisen/status/1633397467420164098?ref=fdaweb.com), Lucira founder **John Waldeisen** called Shuren’s statement “bizarre” and strange that FDA felt the need to comment. “It's shocking to find Lucira's submission information publicly disclosed,” and he questioned whether the disclosure violated FDA commercial confidential information regulations.

***FDA Webview*** has asked CDRH to explain how this criticism about the protracted review fits its misinformation definition of posing enormous dangers to the effectiveness of science and to public health, and why it disclosed details of the company’s submission.