Cue Health, Inc. – FDA Warning Letter, Nov 3, 2023

The FDA issued a Warning Letter to Cue Health, Inc. following an inspection from October 17 to November 3, 2023. The inspection revealed non-compliance with Conditions of Authorization for the Cue Health COVID-19 Test (EUA200248) and the Cue Health COVID-19 Test for Home and OTC Use (EUA210180).

The primary violations include: 1. **Unauthorized Device Modifications:** Cue Health implemented significant changes to its EUA-authorized devices, including modifications to the formulation of a substrate, the (b)(4), and firmware updates (CP-4166 on October 23, 2023), without prior FDA authorization. These changes may negatively impact device stability and performance. The FDA deems these modifications significant and has prohibited distribution of the modified devices until authorization is received. 2. **Inadequate Lot Release Activities:** The firm's lot release activities, specifically the Acceptable Quality Level (AQL) for functional testing of COVID-19 cartridges, are insufficient. An AQL of (b)(4)% allows for a higher failure rate than the claimed 99.1% Negative Percent Agreement (NPA), potentially leading to increased false positive results.

Cue Health is required to cease sale and distribution of the modified tests immediately. The firm must submit a written response within fifteen business days detailing corrective actions, a prevention plan, and a