FDA Update

FDA Advises Against Using Cue Health COVID-19 Tests, Sends Warning Letter

THIS should not be coming as a surprise. The FDA is back going out to the companies and performing inspections. Many companies that may have been operating under the EUA from Covid days, are now being inspected and running into FDA regulatory problems.

You need to know and understand the FDA QSR/cGMP regulations and how they pertain to Change Control and most importantly, CAPA or you could run into the same problem as well.

Agency inspectors found Cue made unauthorized changes to its COVID-19 kits that “reduced the reliability of their tests.”

Cue company markets and distributes the Cue Health COVID-19 Test and the Cue Health COVID-19 Test for Home and Over The Counter (OTC) Use. Each of the tests was authorized by FDA under the Emergency Use Authorization (EUA).

During the pandemic, Cue operations expanded quickly after securing investment and contracts from the government and private firms. They hoped to expand a diagnostic platform and portfolio of cartridges for different diseases and to move the testing from central labs to the home or point of care. However, COVID-19 sales collapsed before Cue could step up other revenue drivers, leading to a series of layoffs.

FDA inspectors visited a Cue facility in San Diego in October and November of 2023. During this assessment, the inspectors found Cue had made “several changes” to its tests, which were used in the home and in patient care settings. This was done without seeking FDA authorization.

Cue changed the formulation of a substrate involved in detecting the SARS-CoV-2 virus and modified the device firmware. The changes ultimately affected the stability of the device performance, which defied the terms of the EUA that had been issued to them by the FDA.

The FDA also said Cue failed to comply with a requirement for lot release activities to ensure the clinical and analytical performance of its tests. Cue’s procedures allowed for the release of tests that failed to hit performance claims, which could result in the release of products with an increased risk of false positive results.

The FDA sent the warning letter on a Thursday and by the following Monday, the agency made the warning letter public. FDA determined the changes made by the company are significant modifications and prohibited the distribution of the modified Cue Health COVID-19 Test or Cue Health COVID-19 Test for Home and Over The Counter (OTC) Use until the new FDA authorizations are received.

FDA stated:

Cue said in a statement, it is “currently evaluating the letter and determining its response, with more information to follow in the next few days.” The company had been scheduled to release its first quarter results this week.

Questions?

If you want a regulatory evaluation of your device(s) design changes and/or your CAPA procedures along with other QSR/cGMP compliance matter, please contact mdi Consultants to set up a mock FDA QSR audit.

PLEASE NOTE: Recently, one of mdi’s clients passed an FDA inspection with NO 483 (list of observations) points. WE can also assist your company to reach the same type of positive outcome.

If you have already been issued a FDA-483 or a warning letter, we can provide qualified assistance in responding to the FDA enforcement correspondence. We have over 46 years of FDA regulatory experience and in dealing with FDA in these types of regulatory situations.

For more information on the subject of Cue Health COVID-19 Tests, please email us at: [email protected] and ref: Cue Health COVID-19 Tests.

For our Auditing Program or FDA regulatory situations, email us at: [email protected] and ref: FDA Regulatory Assistance.