FDA's device labeling rules sit mainly in 21 CFR Part 801, which requires the manufacturer's name, adequate directions for use or a valid exemption, and a unique device identifier. Since February 2, 2026, 21 CFR 820.45 also requires you to check labels for accuracy before release.
Key takeaways
- 21 CFR Part 801 has 38 sections in six active subparts, covering general rules, unique device identification, over-the-counter devices, exemptions and rules for specific devices.
- Every date on a device label must use the year-month-day format, such as 2026-10-01, under 21 CFR 801.18.
- If your label includes any foreign language, every required statement must also appear in that language, under 21 CFR 801.15(c)(2).
- The old labeling rule, 21 CFR 820.120, no longer exists. Since February 2, 2026, 21 CFR 820.45 sets FDA's labeling and packaging controls.
- By our count, labeling problems caused 7.1% of recall events with a known cause in 2025, and labeling change control was the most common labeling cause.
What counts as labeling under FDA rules?
Labeling is much wider than the label. Under section 201(k) of the Federal Food, Drug, and Cosmetic Act, the label is the written, printed or graphic matter on the device's immediate container [3].
Labeling, under section 201(m), is all labels plus any other written, printed or graphic matter on the device or its containers, or accompanying it [3]. FDA reads "accompanying" broadly. It covers posters, tags, pamphlets, brochures, instruction books and direction sheets, not only what ships in the box [3].
So your instructions for use, your carton and your product brochure are all labeling, and all of them must be accurate. Our FDA labeling overview gives the short version.
What does 21 CFR Part 801 require, section by section?
21 CFR Part 801 has 38 active sections in six subparts [1]. We read all 38 as published on eCFR on September 1, 2026, and summarized each one below in plain English. Always read the full text on eCFR before you act on a summary.
Subpart A: General labeling provisions
| Section | What it requires |
|---|---|
| 801.1 | The label of a packaged device must name the manufacturer, packer or distributor and its place of business, conspicuously |
| 801.3 | Definitions used in Part 801, such as automatic identification and data capture |
| 801.4 | What "intended uses" means, which decides what your labeling must cover |
| 801.5 | Adequate directions for use: directions under which a lay person can use the device safely for its intended purposes |
| 801.6 | A false or misleading statement about another device, drug, food or cosmetic makes your device misbranded |
| 801.15 | Required statements must be prominent and in English, and sets when symbols may replace text |
| 801.16 | Prescription devices sold in Puerto Rico may be labeled only in Spanish |
| 801.18 | Dates on the label must use the year-month-day format, separated by hyphens |
Subpart B: Unique device identification (UDI)
| Section | What it requires |
|---|---|
| 801.20 | Every device label and every device package must bear a UDI |
| 801.30 | General exceptions, such as Class I devices exempt from FDA's quality system rule |
| 801.35 | A device that does not need a UDI may carry one voluntarily |
| 801.40 | The UDI must appear in plain text and in machine-readable form, such as a barcode |
| 801.45 | Devices used more than once and reprocessed between uses must carry the UDI on the device itself |
| 801.50 | How stand-alone software meets the UDI rules, including showing its version number |
| 801.55 | How to request an exception from, or alternative to, a UDI requirement |
| 801.57 | Old NHRIC and NDC numbers must come off the label once the UDI applies |
Subpart C: Over-the-counter devices
| Section | What it requires |
|---|---|
| 801.60 | Defines the principal display panel, which must hold all mandatory label information |
| 801.61 | A statement of identity on the principal display panel |
| 801.62 | A declaration of the net quantity of contents |
| 801.63 | Warnings for devices containing or made with chlorofluorocarbons or other ozone-depleting substances |
Subparts D and E: Exemptions from adequate directions for use
| Section | What it allows |
|---|---|
| 801.109 | Prescription devices are exempt if conditions are met, including a label bearing "Rx only" or an equivalent statement |
| 801.110 | Prescription devices delivered to the user by a licensed practitioner |
| 801.116 | Devices whose directions for common uses are known to ordinary people |
| 801.119 | In vitro diagnostic products that meet Subpart B and 21 CFR 809.10 |
| 801.122 | Devices intended for processing, repacking or use in manufacturing |
| 801.125 | Prescription devices supplied for teaching, law enforcement, research or analysis |
| 801.127 | When an exemption expires, such as a shipment to someone not covered by it |
| 801.128 | Exceptions for devices held by the Strategic National Stockpile |
| 801.150 | Devices shipped to be processed, labeled or repacked at another establishment |
Subpart H: Special requirements for specific devices
Nine sections add labeling rules for particular devices [1].
| Section | Devices it covers |
|---|---|
| 801.405 | Denture repair and refitting kits for home use |
| 801.410 | Impact-resistant lenses in eyeglasses and sunglasses |
| 801.415 | Devices that produce ozone |
| 801.417 | Chlorofluorocarbon propellants |
| 801.422 | Prescription hearing aids |
| 801.430 | Menstrual tampons |
| 801.433 | Prescription devices made with ozone-depleting substances |
| 801.435 | Latex condoms |
| 801.437 | Devices containing natural rubber |
What goes on the label, the package and the instructions for use?
Required elements are spread across three places: the label, the package and the instructions for use. This table shows where each one must appear.
| Element | Where it must appear | Rule |
|---|---|---|
| Name and place of business of the manufacturer, packer or distributor | The label of a packaged device | 801.1 |
| Unique device identifier | The label and every device package, plus the device itself if it is reused and reprocessed | 801.20, 801.45 |
| "Rx only" or an equivalent statement (prescription devices) | The label | 801.109(b) |
| Indications, hazards, contraindications, side effects and precautions (prescription devices) | Labeling on or within the dispensing package, usually the instructions for use | 801.109(c) |
| Adequate directions for use (other devices) | The labeling | 801.5 |
| Statement of identity and net quantity (over-the-counter devices) | The principal display panel | 801.61, 801.62 |
| Any printed date, such as the expiration date | Wherever it appears, in year-month-day format | 801.18 |
| A statement locating the symbols glossary, if you use stand-alone symbols | On or within the package | 801.15(c) |
| Latex caution statement | Every label and piece of labeling, including each layer of packaging | 801.437(d) |
Source: 21 CFR Part 801 [1].
Your clearance tells you which rules apply. Your Indications for Use form, FDA Form 3881, records whether your device is cleared for prescription use under Subpart D, over-the-counter use under Subpart C, or both [10]. Label for the use FDA cleared.
Electronic instructions for use are allowed in some cases. Required labeling for prescription devices used in health care facilities or by health care professionals may be provided only electronically, as may labeling for in vitro diagnostic devices used by health care professionals [12]. You must still give users the chance to request a paper copy, and provide it promptly when they do.
How does labeling connect to your 510(k)?
Your labeling is part of your submission. A 510(k) must include proposed labels, labeling and advertisements that describe the device, its intended use and its directions for use [9].
Keep your final labeling consistent with your clearance. The indications on your label and in your instructions for use should match the indications FDA cleared.
Changing your labeling can require a new 510(k). FDA's guidance on deciding when to submit a 510(k) for a change, issued October 25, 2017, has a full section on labeling changes [11]. Our guide on when a device change needs a new 510(k) walks through the decision.
What changed for labeling on February 2, 2026?
The Quality Management System Regulation (QMSR) replaced FDA's old quality system rule, and with it the labeling section many guides still cite. 21 CFR 820.120 no longer exists. Its replacement is 21 CFR 820.45, "Device labeling and packaging controls" [2].
820.45 adds to the ISO 13485 production controls that the QMSR incorporates. You must examine labeling and packaging for accuracy before release [2]. The check covers four things:
- the correct UDI or universal product code
- the expiration date
- storage and handling instructions
- any additional processing instructions
You must also document the release of labeling for use, and run labeling and packaging operations that prevent mix-ups [2]. That includes inspecting labeling before use and documenting the results. Our QMSR guide explains the rest of the regulation.
What do the UDI rules require?
Every device label and every device package must bear a unique device identifier, unless an exception applies [1]. The UDI must appear in two forms: plain text and a machine-readable format such as a barcode [1].
A UDI has two parts. The device identifier is always required and identifies the model or version. The production identifier carries the lot or batch number, serial number, manufacturing date or expiration date whenever your label shows them [1, 5].
Some devices need a direct mark. A device used more than once and reprocessed before each use must carry the UDI on the device itself [1].
The Class I exception is narrower than many assume. Only Class I devices that FDA has exempted from the quality system rule are excepted from the UDI requirement [1]. FDA's policy of not enforcing GUDID submission for most Class I and unclassified devices ended on December 8, 2022 [4]. Devices labeled on or after September 24, 2023 must not carry old NHRIC or NDC numbers [4].
The identifier comes from an FDA-accredited issuing agency, and each device's record is published in FDA's Global Unique Device Identification Database (GUDID) [5, 8]. When we checked FDA's openFDA copy on September 24, 2026, it held 5,182,695 device identifiers [6]. Anyone can search them through AccessGUDID, which our guide to FDA's medical device databases covers.
You can submit GUDID records yourself. FDA offers a web application for one device at a time, and an HL7 SPL route for bulk uploads [8]. Complizen's UDI Submission service does this for you: it creates and publishes your records and confirms that the identifier printed on your labeling matches them. Either way, you obtain the identifier itself from an issuing agency.
Which Part 801 sections apply to a real device?
Here is a polymer patient examination glove, product code LZA. By our count, it accounts for 41 of the 57 FDA clearances won by Malaysian applicants since 2023 [6]. It is Class I, and FDA has not exempted it from the quality system rule [7].
| Requirement | Polymer exam glove (LZA) |
|---|---|
| Name and place of business (801.1) | Required on the label |
| Directions for use (801.5) | Required, unless the glove is cleared for prescription use, in which case 801.109 applies; your Form 3881 shows which |
| Date format (801.18) | Any expiration date must read year-month-day, such as 2028-03-31 |
| UDI on label and package (801.20) | Required, because the Class I exception in 801.30 does not apply to LZA |
| Latex caution statement (801.437) | Not required for a polymer glove; required for a latex glove (product code LYY) |
| Labeling inspection before release (820.45) | Required |
| A second language on the label (801.15(c)(2)) | Allowed, but every required statement must then appear in that language too |
Sources: 21 CFR Part 801 [1], 21 CFR 820.45 [2] and FDA's classification entry for LZA, which we checked on September 25, 2026 [7].
The latex row shows how one material changes the label. A glove made with natural rubber latex must carry this statement in bold: "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" [1]. A device made with dry natural rubber carries a different statement: "This Product Contains Dry Natural Rubber" [1].
If you manufacture in Malaysia, our guide on whether an MDA registration helps with FDA clearance covers what transfers. To find your own product code, see our guide to FDA medical device classification.
How often do labeling errors cause recalls?
Often enough to budget for. By our count of FDA's recall records, labeling problems caused 51 of the 718 recall events initiated in 2025 with a known cause, or 7.1% [6].
| Labeling root cause FDA recorded, 2025 | Recall events |
|---|---|
| Labeling change control | 19 |
| Labeling design | 18 |
| Error in labeling | 10 |
| Labeling mix-ups | 3 |
| Labeling false and misleading | 1 |
Source: we ran this count on September 24, 2026, across the 945 device recall events initiated in 2025, via openFDA [6].
Change control is the biggest single cause. When you change a device, a supplier or a process, the labeling must change with it, through the same controlled process. Mix-ups are the risk that 820.45 now targets directly, through inspection before use [2]. Our medical device recalls guide covers what a recall involves.
Your indications must match your clearance. Claims that go beyond what FDA cleared are a labeling risk in their own right. Our after-clearance guide covers what you can legally claim once you are cleared.
Complizen's Label Review reads your label artwork, carton artwork and instructions for use against Part 801 and against the clearance you actually hold. You get a marked-up version showing what complies and what does not, signed by a named specialist, before you print.
What do manufacturers outside the US get wrong on labels?
Four rules matter most if you label for the US from abroad.
Required statements must be in English. The only exception is for devices distributed solely in Puerto Rico or a US territory where another language predominates [1].
A second language brings every requirement with it. If your label includes Korean, Malay or any other language, all required statements must also appear in that language [1]. Adding a translated tagline alone does not comply.
Local date formats do not comply. Dates must read year-month-day with hyphens, such as 2027-06-30, whatever format you use at home [1].
Symbols need a glossary. A symbol can stand alone without English text only under three conditions [1]. It must come from a standard FDA recognizes, be used as that standard specifies, and be explained in a symbols glossary that ships with the labeling.
Frequently asked questions
What is 21 CFR Part 801?
21 CFR Part 801 is FDA's main medical device labeling regulation, with 38 active sections in six subparts. They cover general rules, unique device identification, over-the-counter devices, exemptions from adequate directions for use, and extra rules for specific devices such as latex products.
What must a medical device label include?
At minimum, the name and place of business of the manufacturer, packer or distributor, adequate directions for use or a valid exemption, and a unique device identifier unless an exception applies. Prescription devices also need "Rx only" or an equivalent statement to qualify for their exemption.
What is the difference between a label and labeling?
The label is the written, printed or graphic matter on the device's immediate container. Labeling is wider: all labels plus anything on or accompanying the device, including instructions for use, cartons, brochures and posters. FDA interprets the word "accompanying" broadly.
Does my device need a UDI?
Almost certainly. Every device label and package must bear a UDI unless an exception applies. The main Class I exception covers only Class I devices that FDA has exempted from the quality system rule. FDA stopped deferring GUDID enforcement for most Class I devices on December 8, 2022.
Can instructions for use be provided electronically?
For some devices, yes. Required labeling for prescription devices used in health care facilities or by health care professionals may be provided only electronically. The same applies to in vitro diagnostic devices for professional use. Users must be able to request a paper copy, provided promptly. Outside these groups, plan on paper labeling.
Can I use symbols instead of text on a device label?
Yes, under three conditions. The symbol must come from a standard FDA recognizes and be used as that standard specifies. It must also be explained in a symbols glossary that ships with the labeling. Otherwise, place explanatory English text next to the symbol.
What does "Rx only" mean on a device label?
It marks a prescription device, one that is safe to use only under the supervision of a licensed practitioner. The label must bear "Rx only", "℞ only" or the statement that federal law restricts the device to sale by or on the order of a named practitioner.
Can my device labeling be in a language other than English?
You can add another language, but required statements must appear in English. If your label includes any foreign language, every required statement must also appear in that language. Only devices distributed solely in Puerto Rico or certain US territories may use another language instead of English.
What replaced 21 CFR 820.120?
21 CFR 820.45, "Device labeling and packaging controls", in the Quality Management System Regulation, effective February 2, 2026. It requires you to examine labeling for accuracy before release, document that release, and prevent mix-ups by inspecting labeling before use. The text is on eCFR under Part 820.
How often do labeling errors cause recalls?
By our count of FDA's records, labeling problems caused 7.1% of recall events with a known cause in 2025, 51 of 718. Labeling change control was the most common labeling cause, followed by labeling design and errors in labeling. Another 227 events were still under investigation.
Do devices containing latex need a special warning?
Yes. Under 21 CFR 801.437, devices containing natural rubber latex that contacts people must carry, in bold, "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions." The statement must appear on the device labeling. Polymer devices such as nitrile gloves do not need it.
What is GUDID, and do I have to submit to it?
GUDID is FDA's Global Unique Device Identification Database, where each device's identifier record is published. Labelers of devices that must bear a UDI submit a record for each device. FDA's openFDA copy held more than 5.1 million device identifiers in September 2026.
References
- eCFR. 21 CFR Part 801, Labeling. Text current as of September 1, 2026.
- eCFR. 21 CFR Part 820, Quality Management System Regulation (including § 820.45). Accessed September 25, 2026.
- FDA. Device Labeling. Accessed September 25, 2026.
- FDA. UDI Compliance Policies and UDI Rule Compliance Dates. Accessed September 25, 2026.
- eCFR. 21 CFR Part 830, Unique Device Identification. Accessed September 25, 2026.
- openFDA. Device API: recall and UDI endpoints. Checked September 24, 2026.
- FDA. Product Classification Database entry for product code LZA. Checked September 25, 2026.
- FDA. Global Unique Device Identification Database (GUDID). Accessed September 25, 2026.
- eCFR. 21 CFR 807.87, Information required in a premarket notification submission. Accessed September 25, 2026.
- FDA. Form FDA 3881, Indications for Use. Accessed September 25, 2026.
- FDA. Deciding When to Submit a 510(k) for a Change to an Existing Device. Guidance issued October 25, 2017.
- Legal Information Institute, Cornell Law School. 21 U.S.C. 352, Misbranded drugs and devices (FD&C Act section 502(f)). Accessed September 25, 2026.