Does promotional material count as labeling?

Yes, under FDA regulations, promotional materials are generally considered part of the device labeling if they accompany the device or are disseminated by the manufacturer in conjunction with the device's sale.

Are electronic Instructions for Use (eIFU) permitted?

Yes, both FDA (e.g., 21 CFR Part 801, Subpart D) and EU MDR (Annex I, Chapter III, Section 23.4) permit eIFU under specific conditions, often requiring a risk assessment and provisions for providing paper copies upon request.

How does cybersecurity relate to labeling?

For devices with cybersecurity features, labeling must clearly communicate cybersecurity-related information, such as recommended security controls, software bill of materials (SBOM), and incident response procedures, as increasingly emphasized by FDA guidance.

All terms

RegulatoryRegulated Pathways

Labeling

All written, printed, or graphic matter on or accompanying a device.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

Per FD&C Act, labeling includes any written, printed, or graphic matter accompanying a medical device, encompassing the IFU, package labels, and patient information leaflets.

What the regulation says

Under 21 CFR Part 801, FDA defines labeling broadly to include all written, printed, or graphic matter accompanying a device, encompassing items like instructions for use (IFU), packaging, and promotional materials. Similarly, the EU MDR (Regulation (EU) 2017/745) details essential requirements for information supplied with the device in Annex I, Chapter III, emphasizing aspects like symbols, electronic instructions, and language requirements.

What this means in practice

Labeling errors are a leading cause of recalls and Form 483 citations. EU MDR adds harmonized symbols and electronic IFU rules.

Examples

A manufacturer includes a detailed instruction for use (IFU) booklet inside the medical device packaging, which details operating procedures and maintenance schedules.
The outer carton of a sterile medical device displays a symbol indicating "do not resterilize" and the universally recognized symbol for "use-by date."
A company provides a dedicated section on its website with downloadable electronic Instructions for Use (eIFU) for its diagnostic equipment, accessible after accepting terms and conditions.

Common pitfalls

•A common pitfall is assuming labeling only refers to the physical label on the device itself; it includes all accompanying information.
•Companies often fail to translate labeling accurately and appropriately for all target markets, leading to non-compliance.
•Inconsistent information across various labeling components (e.g., IFU, website, promotional materials) can lead to regulatory scrutiny.
•Overlooking the need for version control and proper document management for all labeling elements is a frequent mistake.
•Failing to validate electronic IFU systems for accessibility, readability, and security can result in regulatory issues.

Frequently asked questions

The primary purpose is to provide users with essential information for safe and effective device use, including indications, contraindications, warnings, precautions, and operating instructions.

Cross-references

Uses

Concepts or artefacts this term builds on.

ISO 15223-1 Symbols

Contains

Sub-elements or required artefacts of this term.

Electronic Instructions for Use(eIFU)

Grouped by theme

Editor's picks

· Hand-selected related concepts

Regulatory

Instructions for Use(IFU)

Information supplied by the manufacturer to inform the user of safe use of a device.

Regulatory

Unique Device Identification(UDI)

System for adequate identification of medical devices through distribution and use.

Risk & Usability Deep Dive

· From this learning path

Quality & Risk

Summative vs. Formative Evaluation

Iterative usability studies (formative) vs. final validation testing (summative) of a device's user interface.

Adjacent lesson

Clinical & Trials

Human Factors Engineering(HFE)

Engineering discipline focused on safe and effective device use by intended users.

Standards

IEC 62366-1

Application of usability engineering to medical devices.

Standards

ISO 14971

International standard for the application of risk management to medical devices.

Primary references

3 sources

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