Post-Market
Customer Notification Letter
In one line
Communication to users notifying them of a safety issue, corrective action, or important product information.
Definition
Required as part of most recalls and FSCAs, customer notification letters identify the affected product, describe the hazard, instruct on actions, and provide a response mechanism. Templates vary by regulator (FDA Recall Communication, EU FSN).
Effective notices use clear subject lines, plain language, specific device identifiers (such as model, lot and UDI), a description of the risk and the required actions, and a response form to confirm receipt. FDA and EU authorities can review drafts, and authorities may publish them. Effectiveness checks track response rates, and follow-up notices may be needed. MDCG and IMDRF provide field safety notice templates.
Why it matters
Effectiveness checks (e.g., response rate ≥ 90%) are scrutinized by FDA recall coordinators.
Common pitfalls
- •Failing to clearly articulate the specific hazard and the potential impact on patient health or user safety is a common pitfall.
- •Not providing explicit, actionable instructions for customers on what to do with the affected product can lead to poor recall effectiveness.
- •Using overly technical or ambiguous language that obscures the urgency and importance of the notification can hinder customer response.
- •Inadequate record-keeping of distributed letters and customer responses can lead to difficulties in demonstrating recall effectiveness to regulators.
- •Neglecting to follow up on non-responses or low response rates can result in enforcement actions for ineffective recalls.
Sources
- 21 CFR Part 7, Recalls · FDA
- EUDAMED Public Site · European Commission
- MDCG Vigilance Guidance · MDCG