Warning letterPosted March 3, 2026
FDA warning letter to Diasol, Inc.
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
FDA posted a warning letter to Diasol, Inc. on March 3, 2026; the letter is dated January 29, 2026. Subject: Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- Diasol, Inc.
- Subject
- Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2026-01-29
- Posted by FDA
- 2026-03-03
- Source
- FDA warning letters ↗
CFR cited
The record cites 21 sections of 21 CFR Parts 801, 803, 807, 820, 830 and 876.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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