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FDA Warning Letter Trends for Medical Devices
Seven of the 30 post-QMSR letters cite ISO 13485 clauses by number. Two cite no section of the CFR at all.
Quality System Violations Behind the FY2025 Increase
Quality system regulation violations were the most common allegation category by far, cited in 45 of FY2025’s 54 letters. Medical Device Reporting failures (26) were a clear second, well ahead of Premarket Notification (9) and Registration and Listing (3).
What to check: if your last internal audit or gap assessment predates this data, that’s a signal to re-baseline before your next inspection window opens.
Run the Inspection Readiness DiagnosticMost-Cited Quality System Categories
Design controls led FY2024 by a wide margin. CAPA led FY2025 and FY2026 by one letter each.
- • Design controls: cited in 21 of FY2026’s 30 quality-system letters. Seventeen of the 21 also cite CAPA.
- • CAPA: cited in 22 of the 30 letters. Seventeen of the 22 also cite design controls. Twelve also cite complaint files.
- • Complaint files: cited in 16 of the 30 letters. Twelve of the 16 also cite CAPA.
ISO 13485 Clauses Cited After the QMSR
Of the 30 letters issued since the QMSR took effect on February 2, 2026, 19 allege a quality-system violation. Thirteen of those 19 cite a section of 21 CFR 820. Seven cite ISO 13485 clauses by number. Two of the seven cite no section of the CFR at all.
What to check: procedures and training records written against old 820 section numbers cite sections that no longer exist. Re-map them to the ISO 13485 clause structure.
Run the QMSR DiagnosticWhich ISO 13485 Clauses
Citations by ISO 13485 Clause
Seven of the 30 post-QMSR letters cite ISO 13485 clauses by number. Between them they cite 30 clause instances. Letters citing each clause family:
Risk management (clause 7.1) and design controls (clause 7.3) tie at the clause level, each cited in 5 of the 7 letters. CAPA is cited in 4 of the 7 letters. Four cited clauses, 4.1.4, 6.3, 6.4.1, and 8.2.6, aren’t reflected in these clause families.
FY2026 Snapshot
FY2026 Citation Categories
FY2026 ended on September 30, 2026, with 56 warning letters. Thirty allege quality-system violations. A letter posted late can still change these counts.
Most-Cited Categories
CAPA led design controls by one letter in both FY2025 and FY2026. Complaint files are third in both years.
Letters Citing ISO 13485 Clauses
Thirteen of the 19 post-QMSR letters that allege a quality-system violation cite 21 CFR 820. Seven cite ISO 13485 clauses by number. Two cite no section of the CFR at all.
Most Registration and Listing Letters Trace to One Sweep
Twelve of FY2026’s 14 Registration and Listing letters trace to a single mid-December 2025 mass-enforcement action against breast binder manufacturers. The other two letters, to Specialty Health Products in July 2026 and Unilam in September 2026, are separate. Outside that cluster, the category is flat with FY2024 and FY2025.
Other Patterns
Fourth Quarter 2025
More Than Half the Quarter Traces to One Single-Day Sweep
A single mass-enforcement action against breast binder manufacturers accounted for 12 of the quarter’s 22 warning letters. All were dated the same day. They centered on registration and listing gaps paired with misleading marketing claims.
A Testing Laboratory in India Drew a GLP Letter
One of the quarter’s 22 letters cited the Good Laboratory Practice regulation, 21 CFR Part 58. It went to a testing laboratory in India.
The Follow-Up
Change in Citation Language
Partly. Thirteen of the 19 post-QMSR letters that allege a quality-system violation cite 21 CFR 820. Seven cite ISO 13485 clauses by number. Two cite no section of the CFR at all.
Persistence of the Top Findings
Partly. CAPA led FY2025 and FY2026 by one letter each, with complaint files third in both years.
FY2025 MDR Increase
No. Medical Device Reporting failures jumped to 26 letters in FY2025 from 10 in FY2024. FY2026 has 13 such letters, fewer than FY2025 (26 letters) and more than FY2024 (10 letters).
Source: warning letters on devices from the FDA's Center for Devices and Radiological Health, its Office of Product Evaluation and Quality, and the Center for Biologics Evaluation and Research. Vellum Strategy Group pulled and coded each letter from the FDA's public postings and tracks the letters by fiscal year.
Past Editions
As of September 9, 2026, CAPA’s lead over Design Controls held through FY2026, the same order as the full FY2025 year. Three letters so far cite ISO 13485 clauses by number.
CAPA overtakes Design Controls as the single most-cited QSR violation. Citation language still references 21 CFR 820 after the QMSR’s effective date. HIV self-collection kits emerge as a concentrated new pattern, five letters in one quarter.
Warning letters climb to 59 for the year, up 31% from 45 in 2024. Design Controls, CAPA, and Complaint Files lead for a second consecutive year. The QMSR takes effect February 2, 2026. Counts as published February 19, 2026. After later postings and a re-coding, calendar 2025 stands at 63 letters and calendar 2024 at 43 letters.
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