Device labeling
Labeling requirements for medical devices are in 21 CFR Part 801. They govern what must appear on the label, how prominently it must appear, and what may not be claimed. Labeling is also how FDA determines a device's intended use, which makes it the document that decides what the device legally is.
21 CFR 801; FD&C Act 502
At a glance
| The regulation | 21 CFR Part 801. Note FDA's spelling: "Labeling", one L. |
|---|---|
| Required on every device in package form | The name and place of business of the manufacturer, packer or distributor, and an accurate statement of the quantity of contents. |
| If you did not make it | The name must be qualified — "Manufactured for", "Distributed by", or wording that expresses the facts. |
| Adequate directions for use | Required by FD&C Act 502(f)(1). Means directions under which a layman can use the device safely for its intended purposes. |
| Prescription devices | Exempt from adequate directions for use if five conditions in 21 CFR 801.109 are met, including the "Rx only" statement. |
| UDI | Required on the label and on every device package, under 21 CFR 801.20. |
| How intended use is judged | On objective intent, shown by labeling claims, advertising, and written or oral statements. |
| Consequence of getting it wrong | The device is misbranded under FD&C Act 502. |
What must be on the label
- The name and place of business of the manufacturer, packer or distributor.
- An accurate statement of the quantity of the contents, by weight, measure or numerical count.
- A unique device identifier.
- Adequate directions for use, unless the prescription device exemption applies.
- Adequate warnings against use in conditions or by persons where use may be dangerous to health.
Required information can fail the prominence test even when it is present. Information may lack the required prominence if it does not appear on the part of the label presented or displayed under customary conditions of purchase. A manufacturer cannot claim insufficient label space while using that space for a representation in a foreign language.
The "Rx only" statement
A device that is not safe except under the supervision of a licensed practitioner, and for which adequate directions for use therefore cannot be prepared, is exempt from the adequate-directions requirement if five conditions are met.
The best known is the label statement. The label must bear either the symbol statement "Rx only", or the statement "Caution: Federal law restricts this device to sale by or on the order of a ___", with the blank filled by the appropriate practitioner. The label must also state the method of the device's application or use.
The other conditions cover the labeling in or on the dispensing package, which must carry information for use including indications, effects, routes, methods, frequency and duration of administration, and relevant hazards, contraindications, side effects and precautions. All labeling bearing information for use must also carry the date of issuance or latest revision.
Questions people ask
Does our labeling need to be in English?
Labeling for the United States market must be in English. Multilingual artwork is permitted, but foreign-language content cannot be used to justify a claim of insufficient space for required English information.
We only distribute. Do labeling rules apply to us?
If you intend the device for a different use than the person you received it from intended, you are required to supply adequate labeling for the new intended use. Distributors and packers can acquire labeling obligations this way.
Can we say "FDA approved"?
Only if you hold a premarket approval. A 510(k) results in clearance, not approval. Describing a cleared device as approved is a false or misleading representation.
Do symbols need explaining?
FDA permits the use of standalone symbols in certain circumstances under 21 CFR 801.15(c), subject to conditions including the use of a symbols glossary. Check the specific requirements before relying on a symbol alone.
When must labeling be finalized?
The proposed labeling goes into the 510(k), because FDA determines intended use from it. Labeling is not a post-clearance task; it is part of the submission that decides the clearance.