Warning letterPosted October 20, 2026
FDA warning letter to Tides Medical LLC
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
FDA posted a warning letter to Tides Medical LLC on October 20, 2026; the letter is dated October 6, 2026. Subject: Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Issuing office: Center for Biologics Evaluation and Research (CBER).
On the record
- Company
- Tides Medical LLC
- Subject
- Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
- Issuing office
- Center for Biologics Evaluation and Research (CBER)
- Letter dated
- 2026-10-06
- Posted by FDA
- 2026-10-20
- Source
- FDA warning letters ↗
CFR cited
The record cites 2 sections of 21 CFR Part 880.
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.
More
Watch Tides Medical LLC
A free account shows the last 7 days of every FDA, SEC and ClinicalTrials.gov source. Pro adds a watchlist: one email when FDA acts on a company you name.
From FDA warning letters. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with Tides Medical LLC. Informational only.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.