Medical Device Labeling Requirements: FDA 21 CFR 801, UDI and QMSR 820.45

Labeling is one of the most inspected and most error-prone parts of a medical device. In the US, FDA treats labeling broadly: it includes the label on the device and package, instructions for use, and even other written, printed or graphic material that accompanies the device. Mistakes can make a device misbranded, which is a serious violation. This guide explains the main US labeling requirements, how the QMSR changed labeling controls and a practical review checklist.

What counts as labeling

Under the FD&C Act, labeling includes labels and other written, printed or graphic matter on the device or its containers, or accompanying it. That covers instructions for use, user manuals, package inserts, patient information and technical brochures. Promotional claims in other materials can also be considered labeling when they accompany the device or explain its use, so sales and marketing material must stay consistent with approved claims.

The main US labeling rules

• 21 CFR Part 801: general device labeling. It covers the name and place of business of the manufacturer, packer or distributor, adequate directions for use, prominence of required statements and special rules for certain devices.
• Prescription devices (801.109): must carry the prescription statement, and the labeling must include adequate information for use, including indications, effects, routes, methods, frequency and duration of use, hazards, contraindications, side effects and precautions.
• Over-the-counter devices: need directions that a lay user can follow safely, so human factors work matters. See usability engineering.
• 21 CFR Part 809: labeling for in vitro diagnostic products.
• UDI (21 CFR Part 801 Subpart B and Part 830): the label and package must carry the UDI in plain text and machine-readable form unless an exception applies. See UDI for medical devices.
• Device-specific requirements: special controls, classification regulations and guidance may add labeling content, for example warnings or performance information.

Labeling must be in English for the US market, and the content must be consistent with your cleared or approved indications for use.

Misbranding: why accuracy matters

A device is misbranded if its labeling is false or misleading, if it lacks required information, or if directions for use are inadequate. Marketing claims that go beyond the cleared intended use can also cause trouble. Keep a clear link between the labeling, the cleared indications in your 510(k), De Novo or PMA, and the design inputs. See 510(k) submission process.

What changed with the QMSR

The Quality Management System Regulation took effect on February 2, 2026, and incorporates ISO 13485:2016 by reference. FDA kept a labeling and packaging section, 21 CFR 820.45, because it considered that ISO 13485 does not specifically address manufacturer labeling inspection. In summary, manufacturers must have procedures for the control of labeling and packaging operations, including examining labeling for accuracy before it is released, with attention to items such as the UDI, expiry dates, storage and handling instructions and processing instructions. Records for these activities must be kept. Check the text of the rule and your procedures. See the QMSR implementation checklist.

Labeling review checklist

1. Indications and claims: match the cleared or approved intended use exactly.
2. Required statements: manufacturer details, prescription statement where it applies, warnings and contraindications.
3. Instructions for use: steps are complete, in the right order and tested with real users.
4. UDI and codes: readable, correct and consistent with GUDID data.
5. Symbols: standardised symbols are used correctly and explained where required.
6. Shelf life and storage: expiry, storage and handling are correct on every packaging level.
7. Version control: only approved versions are printed, and obsolete stock is controlled. See design controls.
8. Inspection: labeling is examined for accuracy before release, and the inspection is recorded.
9. Change control: label changes are assessed for regulatory impact, including a possible new submission or new UDI-DI.

Common mistakes

• Updating the label but not the instructions, packaging or website content.
• Old labeling left in the warehouse or distribution chain.
• Claims in brochures that go beyond the cleared indications.
• Mismatch between the printed UDI and registered data.
• Complaints about use errors that nobody connects back to unclear labeling. See CAPA and complaint handling.

Frequently asked questions

Is a website part of labeling?

It can be. Content that accompanies the device or promotes its use can be treated as labeling or advertising, so keep it consistent with cleared claims.

Do I need a new submission for a label change?

Not always. Changes to indications, warnings or instructions that could significantly affect safety or effectiveness may need one. Assess each change under your change control process and FDA’s guidance on modifications.

Does the EU use the same labeling rules?

No. The EU MDR has its own labeling requirements in Annex I, including CE marking, the symbols and language rules of each member state. Plan labeling for each market.

Who approves labeling inside the company?

Usually regulatory affairs, quality and the product owner, under a controlled document process.

Talk to the AptSkill team

Need training on labeling, UDI and QMSR requirements for your regulatory and quality teams? Send us a message.