FDA Medical Device Labeling Requirements: 21 CFR Part 801 Explained

21 CFR Part 801 is the FDA regulation on medical device labeling. This page answers the questions we see most often about it, in short, with the source for each.

Last reviewed 18 October 2026. This page is general information about 21 CFR Part 801 and related FDA requirements. It is not legal or regulatory advice, and it may not reflect the latest version of the regulations or guidance. Check the current text on the eCFR and consult your own regulatory affairs or legal advisers before relying on it for compliance decisions. Requirements differ by device class, intended use and market.

What is 21 CFR Part 801?

Part 801 sets the general labeling provisions for medical devices in the US: what a label must say, how clearly it must say it, which statements are misleading, and when a device must carry a unique device identifier. Some devices have additional requirements elsewhere in Title 21.

What must the label say about the manufacturer? (801.1)

The label of a device in package form must conspicuously show the name and place of business of the manufacturer, packer or distributor (801.1(a)). A few details matter in practice:

• Corporate names. A corporation uses its actual corporate name (801.1(b)).
• If it is not the manufacturer. The name must be qualified by a phrase that shows the connection, such as “Manufactured for” or “Distributed by” (801.1(c)).
• Address. The place of business includes street address, city, State and ZIP Code. The street address can be left out if it appears in a current city or telephone directory (801.1(d)). If the device is made or distributed elsewhere, the label may show the principal place of business unless that would be misleading (801.1(e)).

What does “intended use” mean for labeling? (801.4)

“Intended use” is the objective intent of the people legally responsible for the device’s labeling. It can be shown by labeling claims, advertising, or oral or written statements, and it can change after the device is placed on the market (801.4).

If a packer, distributor or seller intends the device for a different use than the party it received it from, that party must supply adequate labeling for the new intended use (801.4). This is why a re-labeler takes on labeling responsibility.

What are “adequate directions for use”? (801.5)

Directions are adequate when a layperson can use the device safely and for its intended purposes (801.5). The regulation lists how directions can fall short, including leaving out or misstating:

• the conditions, purposes or uses the device is intended for
• the quantity or dose, including for different uses, ages and physical conditions
• how often and for how long it is used or applied
• timing relative to meals, symptoms or other factors
• the route or method of use
• preparation for use, such as temperature adjustment

There is an exception for devices that can be used safely only under the supervision of a licensed practitioner and are advertised only to practitioners. The next section covers it.

What is different for prescription devices? (801.109)

A prescription device that cannot have adequate lay directions can be exempt from the directions-for-use requirement, but only if it meets conditions (801.109). In summary:

• It is sold only to, or on the order of, a licensed practitioner for use in professional practice.
• Its label bears “Rx only” (or “℞ only”), or the statement “Federal law restricts this device to sale by or on the order of a [practitioner type]” (801.109(b)(1)). Surgical instruments are handled separately.
• Labeling provided with the device carries the use information, hazards, contraindications and precautions that practitioners need, unless they already commonly know it for that device (801.109(c)).
• Other labeling that gives use information must be adequate, and labeling beyond labels and cartons shows its issue or revision date (801.109(d) and (e)).

What counts as a false or misleading statement? (801.6)

A device’s labeling is misbranded if it contains a false or misleading representation about another device, a drug, a food or a cosmetic (801.6). The Federal Food, Drug, and Cosmetic Act separately treats labeling that is false or misleading about the device itself as misbranding.

How prominent do required statements have to be? (801.15)

Required information must be conspicuous, not just present. 801.15 gives examples of what makes required label text deficient, including:

• it is not on the panel customarily displayed at purchase, or is missing from panels that have room for it
• the type is too small or too stylised, or the background contrast is too low
• designs or crowded text obscure it
• space is taken up by non-required content, or other information is made more prominent than required information

801.15 sets no fixed type size or contrast minimum. It treats small or stylised type and poor contrast as defects, so label design decisions are judged against the rule’s wording. The “not enough room” exemption does not apply if the lack of room comes from non-required words or designs, or from foreign-language text (801.15(b)).

Can we use symbols and other languages? (801.15(c))

Required information must be in English (or the predominant language in Puerto Rico or the territory) or in a symbol. A symbol must either sit next to explanatory text, or be in an FDA-recognised standard or a standards development organisation standard that meets the rule’s conditions, used as the standard specifies, and explained in a glossary in the labeling. The package must say where the glossary is. A symbol that meets neither route can make the device misbranded.

If the label contains any foreign-language text, all required information on the label must also appear in that language. The same applies to the labeling as a whole (801.15(c)(2) and (3)).

Does the device need a UDI? (801.20 and 801.40)

Generally yes. The label of every medical device, and each device package, must bear a unique device identifier (801.20(a)). Exceptions are in 801.30, 801.45 and 801.128(f)(2), and 801.55 covers requests for an exception or alternative.

A UDI must be presented two ways: as easily readable plain text, and in automatic identification and data capture (AIDC) form such as a barcode (801.40(a)). If the AIDC is not obvious on sight, the label or package must disclose that it is there (801.40(c)). A class I device that carries a Universal Product Code (UPC) on its label and packages is deemed to meet these requirements, and the UPC then serves as the UDI (801.40(d)).

UDI formats, issuing agencies and data submission are set by Part 830 and the FDA’s UDI pages, not by Part 801 alone.

Do labeling controls still apply under the QMSR?

Yes. The FDA’s Quality Management System Regulation (QMSR) took effect on 2 February 2026 and incorporates ISO 13485:2016 by reference. 21 CFR 820.45 adds device labeling and packaging controls on top of the ISO text. It asks manufacturers to:

• maintain procedures for the integrity, inspection, storage and operation of labeling and packaging
• examine labeling and packaging for accuracy before release or storage, including the correct UDI or other device identifiers, expiration date, and storage and handling instructions (820.45(a))
• document the release of labeling for use (820.45(b))
• prevent mixups, and inspect labeling before use to confirm each device has the correct labeling and packaging, as specified in the medical device file, with the results documented (820.45(c))

How does this apply to labeling software?

The rules above come down to getting the right content onto the right label every time, and being able to show it. A controlled labeling process keeps approved content, label versions, approvals and regulatory data in one place, so that what prints matches what was approved. If those records are kept electronically, Part 11 applies to them: see our guide to 21 CFR Part 11, and how RONOVA approaches compliance and validation.

For how labeling requirements vary by device class, see Class I and Class II medical devices.