Labeling
All written, printed, or graphic matter on or accompanying a device.
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 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.
- •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.
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Related terms
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Engineering discipline focused on safe and effective device use by intended users.
Application of usability engineering to medical devices.
International standard for the application of risk management to medical devices.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Mentioned in recent activity
11 entriesLatest in MedTech
Recent regulatory actions, publications, and trials matched to this term. Updated daily.
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PubMed2026-05-01Effects of project management in labeling standardization for new reusable medical device packages: A retrospective study.
The Journal of international medical research
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Recall2026-04-24HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Class II · Devicor Medical Products Inc
Primary references
3 sources- 1
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 2
RAPS Regulatory FocusVerifiedRAPSraps.org
- 3
FDA - Medical DevicesVerifiedFDAfda.gov
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