Labelling Requirements — 21 CFR Part 801
What is "labelling"?
Under FD&C Act § 201(m), labelling includes all written, printed, or graphic matter:
- On the device itself
- On any container or wrapper
- Accompanying the device (e.g., instructions for use, promotional materials)
This is significantly broader than the physical label — it encompasses IFUs, package inserts, advertising, and promotional materials.
Required label information (21 CFR § 801.1)
| Information | Required? |
|---|---|
| Name and place of business of manufacturer, packer, or distributor | Yes |
| Quantity of contents | Yes (if applicable) |
| Adequate directions for use | Yes (unless exempt) |
| Warnings, cautions, and precautions | Yes |
| Storage and handling information | If applicable |
| Expiration date | If applicable |
| Lot or batch number, serial number, or manufacturing date | Yes |
| UDI (unique device identifier) | Yes (for applicable devices) |
Special requirements for prescription devices
Prescription devices (those restricted to sale, distribution, or use by/on the order of a licensed practitioner) must bear the statement: "CAUTION: Federal law restricts this device to sale by or on the order of a ___" (completing the blank with the applicable licence type: physician, dentist, etc.) — per 21 CFR § 801.109.