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
Related terms
Shared paths + categoryRegulatory
Instructions for Use(IFU)
Information supplied by the manufacturer to inform the user of safe use of a device.
Same category
Regulatory
Unique Device Identification(UDI)
System for adequate identification of medical devices through distribution and use.
Same category
Quality & Risk
Summative vs. Formative Evaluation
Iterative usability studies (formative) vs. final validation testing (summative) of a device's user interface.
Risk & Usability Deep Dive · adjacent
Clinical & Trials
Human Factors Engineering(HFE)
Engineering discipline focused on safe and effective device use by intended users.
Risk & Usability Deep Dive
Standards
IEC 62366-1
Application of usability engineering to medical devices.
Risk & Usability Deep Dive
Standards
ISO 14971
International standard for the application of risk management to medical devices.
Risk & Usability Deep Dive
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
IMDRF·1RAPS·1FDA·1
- 1IMDRF DocumentsVerifiedIMDRFimdrf.org
- 2RAPS Regulatory FocusVerifiedRAPSraps.org
- 3FDA - Medical DevicesVerifiedFDAfda.gov
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