Regulatory Insights: What Medical Device Manufacturers Should Know About U.S. Labeling
_A concise overview of selected FDA labeling requirements under 21 CFR Part 801
Medical device labeling requirements in the United States vary by device type, intended use, regulatory classification, and applicable regulations. This article highlights selected general requirements under 21 CFR Part 801 and should not be treated as a complete labeling checklist.
Under the Federal Food, Drug, and Cosmetic Act, a label generally refers to written, printed or graphic matter displayed on the immediate container of an article. Labeling is broader and includes labels and other written, printed or graphic matter that accompanies the article. FDA explains that labeling may include instructions, brochures, direction sheets, and similar materials. FDA: Device Labeling
Name and Place of Business
The label of a medical device in package form must conspicuously state the name and place of business of the manufacturer, packer, or distributor.
If the company named on the label did not manufacture the device, its relationship to the device must be identified using wording such as:
“Manufactured for”
“Distributed by”
Other wording that accurately describes the relationship
Section 801.1 also contains requirements concerning the business address and specifies certain circumstances in which the principal place of business may be used. 21 CFR §801.1
OTC Device Identity and Net Quantity
For an over-the-counter medical device sold in a package, the principal display panel must include a statement of identity. Section 801.61 defines this as the device's common name followed by an accurate statement of its principal intended action.
The label must also declare the net quantity of contents by weight, measure, numerical count, or an appropriate combination of numerical count and weight, measure, or size. Additional requirements govern the placement, prominence, and formatting of this declaration.
Unique Device Identification, Where Applicable
Under the general UDI rule, device labels and device packages must bear a unique device identifier unless an applicable exception or alternative applies.
When a UDI is required, it must be presented in two forms:
Easily readable plain text
Automatic identification and data capture, or AIDC, technology
If a device label includes a lot or batch number, serial number, manufacturing date or expiration date, §801.40 requires the UDI to include the applicable production identifier information.
Additional provisions in Part 801 address UDI exceptions, alternatives and direct marking requirements. 21 CFR Part 801, Subpart B
Date Format
When a medical device label includes an expiration date, manufacturing date or another date intended to be brought to the user’s attention, the date generally must use the following format:
YYYY-MM-DD
For example:
MFG: 2026-08-01
EXP: 2029-08-01
Section 801.18 provides exceptions for certain combination products and certain electronic products subject to radiological health requirements. 21 CFR §801.18
Additional Requirements for Certain Prescription Devices
A prescription device relying on the exemption in §801.109 is subject to the conditions specified in that section.
Except for surgical instruments, the device label must bear “Rx only,” “℞ only,” or the longer restriction statement permitted by the regulation, together with the method of application or use.
The labeling must also provide the applicable information needed for licensed practitioners to use the device safely for its intended purposes, subject to the provisions and exceptions contained in the regulation. 21 CFR §801.109
Symbols and Languages
Required labeling information must be sufficiently prominent and presented in a form permitted by §801.15.
The regulation permits certain symbols to be used without adjacent explanatory text when the applicable conditions are satisfied. Depending on the symbol and standard used, a paper or electronic symbols glossary may be required.
If a label contains a representation in a foreign language, the required label information must also appear in that language. A corresponding requirement applies when a foreign language appears in other labeling. 21 CFR §801.15
General Points for a Device-Specific Labeling Review
Depending on the device and its regulatory status, a labeling review may include:
Device name, model and specifications
Manufacturer, packer or distributor information
OTC or prescription status
UDI applicability and presentation
Lot, serial-number and date information
Net quantity requirements for OTC devices
Intended use and directions for use
Applicable warnings and precautions
Symbols and language requirements
Device-specific labeling provisions
These are general review points, not an official or universal FDA checklist. In addition to 21 CFR Part 801, manufacturers should identify any requirements associated with the device’s classification, applicable regulation, product code, marketing authorization and other relevant FDA requirements.
Careful, device-specific labeling review can help manufacturers identify applicable requirements before their devices are introduced into the U.S. market.
This article is provided for general informational purposes only. It does not constitute legal or regulatory advice, does not address every potentially applicable requirement, and should not be relied upon as a determination of compliance for any particular device.
Symbols and Languages
Required labeling information must be sufficiently prominent and presented in a form permitted by §801.15.
The regulation permits certain symbols to be used without adjacent explanatory text when the applicable conditions are satisfied. Depending on the symbol and standard used, a paper or electronic symbols glossary may be required.
If a label contains a representation in a foreign language, the required label information must also appear in that language. A corresponding requirement applies when a foreign language appears in other labeling. 21 CFR §801.15
This article is provided for general informational purposes only. It does not constitute legal or regulatory advice, does not address every potentially applicable requirement, and should not be relied upon as a determination of compliance for any particular device.
