Why Labeling Is a Critical Compliance Area
Device labeling is one of the most frequently cited areas during FDA inspections. A label deficiency can delay clearance, trigger a Form 483, or result in a misbranding violation — all of which can halt your product's market access.
What Counts as "Labeling"?
Under FDA regulations, labeling includes far more than just the physical label affixed to the device. It encompasses:
- The device label itself
- Packaging inserts and instructions for use (IFU)
- Product brochures and promotional materials
- Website content describing the device's intended use
Mandatory Label Elements (21 CFR Part 801)
Every device label must include:
- Name and place of business of the manufacturer, packer, or distributor
- Adequate directions for use — unless exempt (e.g., prescription devices)
- Quantity of contents — for packaged devices
- Proprietary and common name of the device
- Lot or batch number, serial number, or manufacturing date
- Expiration date — where applicable
- UDI on the label and device package (see our UDI guide)
Prescription Device Labeling (21 CFR 801.109)
Prescription devices must include the statement:
"Caution: Federal law restricts this device to sale by or on the order of a physician."
Or alternatively: "Rx only"
In Vitro Diagnostic Labeling
IVDs have additional requirements under 21 CFR 809.10, including:
- Intended use and clinical significance
- Summary of test principle
- Reagent composition
- Specimen collection and handling
- Reference intervals
Common Labeling Deficiencies Found During Inspections
- Missing or incorrect UDI
- Inadequate directions for use for OTC-marketed devices
- Lack of bilingual labeling when marketed in Puerto Rico or Canada
- Promotional claims that exceed cleared indications
- Outdated labeling not updated after a device change
Labeling for the Canadian Market
Health Canada requires that device labels sold in Canada include:
- Bilingual content (English and French)
- Canadian importer/distributor information
- Compliance with the Medical Devices Regulations (SOR/98-282)
How United Regulatory Can Help
Our team reviews device labeling against 21 CFR Part 801, IFU adequacy, UDI compliance, and Canadian bilingual requirements. We catch issues before FDA does. Contact us for a labeling audit.