🚫FDA Revokes Emergency Use Authorization for LumiraDx Device
Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Summary
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to LumiraDx UK Ltd. for the LumiraDx SARS CoV-2 RNA STAR Complete. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reason for revocation, is reprinted at the end of this document.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The text details the revocation of an Emergency Use Authorization for a COVID-19 diagnostic device by the FDA, signaling compliance and regulatory requirements that could impact businesses involved in healthcare and diagnostics. Companies may need to adjust strategies around product offerings and regulatory compliance due to this action.