--- title: "Customer Notification Letter, Definition | MedTech Terms" description: "Communication to users notifying them of a safety issue, corrective action, or important product information. Plain-English Post-Market definition for MedTech t" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/customer-notification#term", "name": "Customer Notification Letter", "description": "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. 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EU MDR also emphasizes verification of the effectiveness of FSCAs." } }, { "@type": "Question", "name": "Are there different templates for Customer Notification Letters?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, templates vary by regulator; for example, the FDA provides guidance for recall communications, and the EU MDR refers to Field Safety Notices (FSNs) which have specific content requirements outlined in MDCG guidance documents." } }, { "@type": "Question", "name": "What kind of information must be included in a Customer Notification Letter?", "acceptedAnswer": { "@type": "Answer", "text": "The letter must identify the affected product, clearly describe the hazard and health risk, outline the required actions from the customer, and provide instructions for how to respond or return the product, including contact information for questions." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Customer Notification Letter [All terms](/terms) Post-Market [Post-Market & Safety](/ecosystems/post-market-safety)[Startup Lifecycle](/ecosystems/startup-lifecycle) # Customer Notification Letter Communication to users notifying them of a safety issue, corrective action, or important product information. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## 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). What the regulation says Customer Notification Letters are a critical component of recall communications, mandated by regulators like the FDA in 21 CFR Part 7, Subpart C, and required for Field Safety Corrective Actions (FSCAs) under the EU [MDR](/terms/mdr-reporting), as detailed in [MDCG](/terms/mdcg) 2021-23. These letters ensure that affected parties are promptly informed about potential risks and necessary actions. The content and distribution are often guided by regulatory standards, such as those outlined by the FDA for recall communications or in the EU Medical Device Coordination Group (MDCG) guidance for Field Safety Notices (FSNs). ## What this means in practice Effectiveness checks (e.g., response rate ≥ 90%) are scrutinized by FDA recall coordinators. ## Examples - A medical device manufacturer issues a Customer Notification Letter to hospitals detailing a software bug in an infusion pump that could lead to incorrect dosage delivery, instructing them to isolate affected units and await a software update. - Following a discovery of a sterility breach in a batch of single-use surgical instruments, a company sends a Customer Notification Letter to clinics advising them to cease use, quarantine the products, and arrange for their return. - A diagnostic company distributes a Customer Notification Letter to laboratories about a lot of test reagents exhibiting false-positive results, providing instructions for disposal and replacement. 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. ## Frequently asked questions What is the primary purpose of a Customer Notification Letter? The primary purpose is to inform customers about a product defect or risk, instructing them on necessary actions to mitigate harm, and ensuring regulatory compliance during a recall or [field safety corrective action](/terms/fsca). How do regulators evaluate the effectiveness of these letters? Are there different templates for Customer Notification Letters? What kind of information must be included in a Customer Notification Letter? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market FDA Recall Classifications I, II, III FDA's risk-based grading of recalls based on potential for harm. ](/terms/recall-classifications)[ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca) ### More in Post-Market · Same category [ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report)[ Post-Market Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. ](/terms/annual-report-pma)[ Post-Market Electronic Medical Device Reporting(eMDR) FDA's mandatory electronic submission system for Medical Device Reports. ](/terms/emdr)[ Post-Market Field Action vs Recall Distinction between corrective field actions taken on devices in the field and FDA-defined recall events. ](/terms/field-action-vs-recall) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 European Commission· 1 MDCG· 1 1. [1 FDA Recall Communications Verified FDA · fda.gov ](https://www.fda.gov/safety/industry-guidance-recalls) 2. [2 EUDAMED Public Site Verified European Commission · ec.europa.eu ](https://ec.europa.eu/tools/eudamed/) 3. [3 MDCG Vigilance Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Post-Market Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=customer-notification) Learn in 60 seconds Card Lesson Quiz Communication to users notifying them of a safety issue, corrective action, or important product information. - · Effectiveness checks (e.g., response rate ≥ 90%) are scrutinized by FDA recall coordinators. - · Templates vary by regulator (FDA Recall Communication, EU FSN). Remember this Watch out: Failing to clearly articulate the specific hazard and the potential impact on patient health or user safety is a common pitfall. Related terms - [FDA Recall Classifications I, II, III ](/terms/recall-classifications) - [Field Safety Corrective Action(FSCA) ](/terms/fsca) You may also need Auto-suggested from Post-Market and shared keywords. - [Field Action vs Recall ](/terms/field-action-vs-recall) - [Health Hazard Evaluation(HHE) ](/terms/health-hazard-eval) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) - [Medical Device Vigilance ](/terms/vigilance) - [Medical Device Recall ](/terms/recall) - [Periodic Safety Update Report(PSUR) ](/terms/psur) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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