Industry Trends
FDA enforcement, tracked quarter by quarter.
Warning letters are up sharply.
Quality system regulation violations were the most common allegation category by far, cited in 38 of the 59 letters. MDR reporting failures (23), registration and listing issues (13), and marketing without clearance or approval (10) rounded out the leading categories.
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 DiagnosticThe same three findings, two years running.
These aren’t obscure or newly introduced requirements. Their persistence at the top of the list for two consecutive years points to systemic weak points across the industry, not isolated missteps at individual firms.
- • Design Controls: most often a Design History File that can’t withstand a second reading.
DHF & V&V work - • CAPA: most often closed on implementation, not on verified effectiveness.
CAPA program overhauls - • Complaint Files: usually a symptom of audit gaps, not a standalone issue.
QMS auditing
QMSR’s first test.
Letters issued after February 2, 2026 still cite 21 CFR 820, since the inspections behind them were conducted before QMSR took effect. But FDA is explicit that corrective actions must be proposed and implemented under QMSR, regardless of which regulation the letter itself names.
What to check: procedures and training records written against old 820 section numbers still need to be re-mapped to ISO 13485 clause structure now, ahead of FDA’s own citation language.
Run the QMSR DiagnosticQ1 2026 Snapshot
Fourteen letters in, CAPA pulls ahead.
Fourteen warning letters were issued in the first quarter of 2026. Three more from late 2025 were posted alongside them. Eleven of the seventeen allege QSR violations.
CAPA takes sole first place.
Process Validation and Nonconforming Product tied Complaint Files at six letters each, a wider spread than the 2025 annual pattern.
Citation language hasn’t shifted yet.
Letters issued after February 2, 2026 still cite 21 CFR 820, since the inspections behind them predate QMSR. FDA is explicit, though: remediation has to follow QMSR, not the regulation the letter names.
A new pattern: HIV self-collection kits.
Five of the quarter’s letters concern at-home HIV self-collection kits, continuing FDA’s position that these are devices requiring clearance or approval, even when distributed alongside a lab-developed test.
Other Patterns Worth Watching
From the fourth quarter of 2025.
12 of 20: the breast binder sweep.
A single mass-enforcement action against breast binder manufacturers accounted for 12 of the quarter’s 20 warning letters, centered on registration and listing gaps paired with misleading marketing claims.
Offshore labs stay under scrutiny.
Continued scrutiny of GLP and data-integrity practices at non-clinical testing labs in China and India.
Distributors are now a target.
A notable share of letters went to distributors, not only device manufacturers, a reminder that enforcement exposure isn’t limited to the party that designs the device.
The Follow-Up
Checking back on what we were watching for.
Three questions from the last update, and where Q1 2026 data leaves them:
Does the citation language change?
Not yet. Letters issued after February 2, 2026 still cite 21 CFR 820, but FDA now requires remediation to follow QMSR regardless of which regulation the letter names.
Do the same three findings hold?
Not exactly. CAPA has pulled ahead as the clear leader, Design Controls holds second, and Complaint Files now shares third with two categories that weren’t previously in the top tier.
Does distributor enforcement continue?
Not addressed in this quarter’s report. Carried forward to the next update.
New this edition: are HIV self-collection kits the start of a broader pattern? Five letters in one quarter is a concentrated cluster. Whether it signals a sustained push into specimen-collection devices, or a one-time sweep, should be clearer in the Q2 2026 data.
Past Editions
What changed, edition by edition.
CAPA overtakes Design Controls as the single most-cited QSR violation. Citation language still references 21 CFR 820 after 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. QMSR takes effect Feb. 2, 2026.
Stay Current
This page updates as new quarterly data is published.
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Trend breakdowns and analysis are posted as new enforcement data lands, ahead of this page’s quarterly update.
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Notify Me on UpdateSources: Covington & Burling LLP, Quarterly Medical Device Warning Letters Update: January – March 2026 (May 15, 2026) and Quarterly Medical Device Warning Letters Update: October – December 2025 and 2025 Annual Summary (Feb. 19, 2026).
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