Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
Short answer: the core FDA rules for what a medical device label and its labeling must carry sit in Title 21 of the Code of Federal Regulations, Part 801. Part 801 is organised by subpart (general provisions, unique device identification, over-the-counter devices, exemptions, special devices), not by device class. This page maps the subparts to what a clinic buyer or student can actually see on a pack, checked against the regulation text on 2026-11-01.
Who this is for: clinic staff, buyers and students who need to read a device label against the regulation. It is a reading guide, not a manufacturer compliance manual. For adjacent topics see private label medical supplies (who is named on the pack), medical device tracking requirements, certificate of free sale for medical devices and export documentation for medical supplies.
Where the FDA medical device labeling requirements live (the Part 801 map)
21 CFR Part 801 is titled “Labeling” and is divided into subparts. The table lists each subpart with the section range shown in the regulation’s table of contents (Cornell Legal Information Institute copy of the CFR, checked 2026-11-01).
| Subpart | Sections | What it covers |
|---|---|---|
| A. General Labeling Provisions | 801.1 to 801.18 | Includes name and place of business (801.1), adequate directions for use (801.5) and prominence of required label statements (801.15) |
| B. Labeling Requirements for Unique Device Identification | 801.20 to 801.57 | Unique device identifier (UDI) on the label and package (801.20) |
| C. Labeling Requirements for Over-the-Counter Devices | 801.60 to 801.63 | Rules specific to over-the-counter devices |
| D. Exemptions From Adequate Directions for Use | 801.109 to 801.128 | Includes prescription devices (801.109) |
| E. Other Exemptions | 801.150 | Further exemptions |
| H. Special Requirements for Specific Devices | 801.405 to 801.437 | Device-specific labeling, for example menstrual tampon absorbency labeling (801.430) |
FDA’s guidance “Labeling – Regulatory Requirements for Medical Devices (FDA 89-4203)”, issued September 1989 (page content current as of 08/31/2018), explains the label and labeling regulations, including misbranding under section 502 of the Federal Food, Drug, and Cosmetic Act, advertising treated as labeling, prominence and directions for use.
What does the label have to say about who made or sold the device? (21 CFR 801.1)
The label of a device in package form must “specify conspicuously the name and place of business of the manufacturer, packer, or distributor” (801.1(a)). Four details follow from the text:
- Actual name: for a corporation the actual corporate name is required; abbreviations such as “Inc.” are allowed (801.1(b)).
- Relationship wording: if the named party did not manufacture the device, the name must be qualified by a phrase that reveals the connection, such as “Manufactured for” or “Distributed by” (801.1(c)).
- Place of business: street address, city, State and ZIP Code; the street address may be omitted if it appears in a current city or telephone directory. For nonconsumer packages the ZIP Code may appear on the label or on the labeling, including the invoice (801.1(d)).
- Principal place of business: may be stated instead of the actual site of manufacture or packing, unless that would be misleading (801.1(e)).
For a buyer, this is the rule behind reading “Distributed by” versus “Manufactured by” on a pack, which matters for private-label products.
What are adequate directions for use? (21 CFR 801.5 and 801.109)
“Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended” (801.5). The section lists what makes directions inadequate when omitted or specified incorrectly, including statements of the intended conditions, purposes or uses, frequency, duration and route or method of application, and preparation for use.
Some devices are not safe except under a licensed practitioner’s supervision, so adequate directions for a layperson cannot be written. Section 801.109 exempts such prescription devices if conditions are met. Among them, the label (other than for surgical instruments) must bear the statement “Rx only” or “Caution: Federal law restricts this device to sale by or on the order of a ___” together with the method of application or use, and labeling on or within the dispensing package must carry information for use by practitioners. See the Rx only symbol and instructions for use for medical devices.
How prominent must required label statements be? (21 CFR 801.15)
Section 801.15(a) lists ways a required statement can lack the prominence the Act demands. Examples from the text: it does not appear on the panel displayed under customary conditions of purchase, label space is used up by information the Act does not require, or the type is too small, the background contrast insufficient, or the statement is crowded by other matter. Section 801.15 also addresses the use of symbols in labeling; see medical device labeling symbols.
Does a UDI have to be on the label? (21 CFR 801.20)
Section 801.20(a) states that the label of every medical device, and every device package, shall bear a unique device identifier that meets Subpart B and Part 830, subject to the exceptions in 801.30, 801.45 and 801.128(f)(2), with 801.55 providing a way to request an exception or alternative. FDA and the National Library of Medicine publish device records by UDI in the AccessGUDID database, which can be searched by device identifier. See UDI labels.
Are the labeling requirements different for class 1 medical devices?
The Part 801 structure above is organised by subpart and section, not by device class. Class is set in each device’s own classification regulation (for example, an irrigating syringe is Class I and exempt from 510(k) premarket notification under 21 CFR 880.6960), while the label is read against Part 801. The Part 801 sections above do not carve out a lighter label for Class I; the exemptions that exist are the ones named in Subparts B, D and E, such as the UDI exceptions in 801.30 and 801.45 and the prescription-device exemption in 801.109. To see how a specific device is classified, check its classification regulation and its AccessGUDID record.
Common mistakes when reading a device label
- Treating a distributor’s name as the manufacturer’s: 801.1(c) requires wording such as “Distributed by” or “Manufactured for” when the named party did not make the device.
- Assuming “Rx only” is optional marketing text: for prescription devices it is a condition of the 801.109 exemption.
- Assuming a low-risk class means no label rules: the Part 801 sections above are not written by class.
- Looking only at the carton: 801.1(d) lets the ZIP Code for a nonconsumer package appear on the labeling, including the invoice.
FAQ
What are the FDA medical device labeling requirements?
They are set mainly by 21 CFR Part 801, which covers general label content such as the manufacturer, packer or distributor name and place of business (801.1), adequate directions for use (801.5), prominence (801.15), the UDI (801.20), over-the-counter devices, exemptions and device-specific rules.
What are the medical device label requirements FDA lists for the name on the pack?
The label of a device in package form must conspicuously state the name and place of business of the manufacturer, packer or distributor, with “Manufactured for” or “Distributed by” style wording when the named party did not make it (801.1).
What are the class 1 medical device labeling requirements?
Part 801 is not divided by class. Class I devices are labeled against the same Part 801 sections as other devices, subject to the exemptions the regulation itself names. Classification is set in the device’s own classification regulation.
Sources
- 21 CFR Part 801, Labeling (structure and subparts), Cornell Legal Information Institute: https://www.law.cornell.edu/cfr/text/21/part-801, checked 2026-11-01.
- 21 CFR 801.1: https://www.law.cornell.edu/cfr/text/21/801.1, checked 2026-11-01.
- 21 CFR 801.5: https://www.law.cornell.edu/cfr/text/21/801.5, checked 2026-11-01.
- 21 CFR 801.15: https://www.law.cornell.edu/cfr/text/21/801.15, checked 2026-11-01.
- 21 CFR 801.20: https://www.law.cornell.edu/cfr/text/21/801.20, checked 2026-11-01.
- 21 CFR 801.109: https://www.law.cornell.edu/cfr/text/21/801.109, checked 2026-11-01.
- 21 CFR 880.6960, irrigating syringe classification: https://www.law.cornell.edu/cfr/text/21/880.6960, checked 2026-11-01.
- FDA, Labeling – Regulatory Requirements for Medical Devices (FDA 89-4203): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-regulatory-requirements-medical-devices-fda-89-4203, checked 2026-11-01.
- AccessGUDID, National Library of Medicine: https://accessgudid.nlm.nih.gov/, checked 2026-10-30.
