Issued to ProDx Health. Serious post-market compliance violation.
Issued
February 10, 2026Product
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Company
ProDx Health
Review center
CBERStage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA issued a warning letter to ProDx Health concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic source-metadata screening identifies discussion of Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
Open the document workspaceFDA source document
FDA publishes this warning letter as a web document.
Open the exact FDA source to read the complete letter and verify its current response or closeout status.
Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on February 10, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.