21 CFR Part 801 — Labelling
21 CFR Part 801 is the core FDA regulation governing medical device labelling. It defines what information must appear on device labels and labelling, and sets out the requirements for prescription and over-the-counter devices.
Structure of Part 801
| Subpart | Content |
|---|---|
| Subpart A (§§ 801.1–801.30) | General labelling provisions — name, address, quantity, adequate directions for use |
| Subpart B (§§ 801.60–801.122) | Labelling requirements for specific device types (hearing aids, etc.) |
| Subpart C (§§ 801.150–801.196) | Labelling of devices for OTC human use |
| Subpart D (§ 801.109) | Prescription devices — Rx labelling requirements |
| Subpart H (§§ 801.400–801.437) | Unique Device Identification (cross-reference to Part 830) |
Key sections
§ 801.1 — Name and place of business
Every device label must bear the name and place of business of the manufacturer, packer, or distributor.
§ 801.4 — Meaning of intended uses
The intended use of a device is determined by the objective intent of the persons legally responsible for labelling — expressed through labelling, advertising, and oral representations.
§ 801.5 — Adequate directions for use
Devices must bear labelling with adequate directions for use — unless exempt (e.g., prescription devices under § 801.109 or IVDs under § 809.10).
§ 801.109 — Prescription devices
A device intended for use only by a licensed practitioner must bear the statement:
"CAUTION: Federal law restricts this device to sale by or on the order of a ___"
Such devices are exempt from the adequate directions for use requirement.
§ 801.15 — Prominence of required label statements
Required label statements must appear prominently and conspicuously — at least half the size of the largest type on the label.
UDI and Part 801
§ 801.20 (added by the UDI rule) requires device labels to include the Unique Device Identifier (UDI) in both human-readable and AIDC formats, in accordance with 21 CFR Part 830.