The short answer
Yes — you can use ISO 15223-1 symbols on medical device labels sold in the US without words next to them, as long as you follow FDA's symbols rule (21 CFR 801.15(c)) and include a symbols glossary. FDA added this option in its final rule Use of Symbols in Labeling, published June 15, 2016.
| Option | Allowed? | Condition |
|---|---|---|
| Text only | Yes | Always allowed |
| Symbol + adjacent text | Yes | No glossary needed |
| Stand-alone symbol | Yes | From an SDO standard (e.g. ISO 15223-1), used as the standard says, explained in a symbols glossary |
| Own (“homegrown”) symbol alone | No | Needs adjacent explanatory text |
What ISO 15223-1 is
ISO 15223-1 sets out the symbols used on medical device labels and instructions worldwide — for example manufacturer, date of manufacture, use-by date, batch code, catalogue number, sterile, do not reuse, and consult instructions for use. Using the same symbols in the US and in other markets lets manufacturers in Germany, Japan, Korea or China keep one label design.
FDA's conditions for stand-alone symbols
Under 21 CFR 801.15(c)(1)(i), a symbol without adjacent text may be used when it:
- 1Comes from a recognized or SDO standardEither a standard FDA recognizes under section 514(c) of the FD&C Act, or one developed by a standards development organization (SDO) — and, for the SDO route, the manufacturer has decided the symbol is likely to be read and understood by the ordinary user.
- 2Is used as the standard specifiesSame design and meaning — no changes to the symbol.
- 3Is explained in a symbols glossaryIncluded with the device labeling.
The rule also allows the statement “Rx only” or “℞ only” on prescription devices (801.15(c)(1)(i)(F), referring to 801.109(b)(1)). Symbols that do not meet these conditions make the device misbranded (801.15(c)(1)(ii)).
The symbols glossary
The glossary is a list of every stand-alone symbol you use, with:
- the symbol itself;
- the title and designation number of the standard (e.g. ISO 15223-1);
- the symbol's title and reference number in that standard;
- its meaning.
If symbols appear without text, the labeling must clearly say where the glossary is. FDA's FAQ explains that it can be on labeling inside the package, and describes an electronic glossary option for small devices without a package insert.
Which edition? ISO 15223-1:2021
FDA recognizes ISO 15223-1, 4th edition (2021-07) as Recognition No. 5-134. FDA has listed a newer recognition that includes Amendment 1:2025 (No. 5-148) and will accept declarations of conformity to 5-134 in premarket submissions until December 17, 2028. Check the FDA recognized standards database before you finalize artwork.
Example
A manufacturer in Germany sells sterile single-use catheters in the EU and the US. It uses the ISO 15223-1 symbols for “sterile”, “do not reuse”, “use-by date” and “batch code” on the pouch without text, adds a symbols glossary to the instructions for use, and states on the label where the glossary can be found.
Other US label elements to check
When you review a device label for the US, symbols are only one part. Also check, under 21 CFR Part 801:
- Name and place of business of the manufacturer, packer or distributor (801.1);
- Adequate directions for use (801.5), or the prescription device conditions in 801.109 for Rx devices;
- Unique Device Identifier (UDI) on the label and package, where required (801.20);
- English language for required statements on devices sold in the US.
Common mistakes
- Using symbols from an old edition, or changing their design
- No symbols glossary, or a glossary missing the standard and reference numbers
- Company-made symbols used without text
- Assuming symbols replace required English text, such as directions for use
Medical device label review against FDA requirements — on your own artwork.
Frequently asked questions
Can I use ISO 15223-1 symbols on US device labels without text?
Yes. Since FDA’s 2016 symbols rule, stand-alone symbols are allowed if they come from a standard developed by a standards development organization — such as ISO 15223-1, which FDA recognizes — are used as the standard specifies, and are explained in a symbols glossary included with the labeling.
What must the symbols glossary contain?
Each symbol used, the title and designation number of the standard, the symbol’s title and reference number in that standard, and its meaning. If symbols appear without text, the labeling must say where the glossary is.
Can I use my own symbols?
Not as stand-alone symbols. “Homegrown” symbols that are not established in a standard from a standards development organization need adjacent explanatory text. Otherwise the device can be considered misbranded.
Does the symbols rule also cover in vitro diagnostics (IVDs)?
Yes. The 2016 Use of Symbols in Labeling rule also changed the labeling rules for in vitro diagnostic products (21 CFR 809.10), so IVD labels can use stand-alone symbols from a standard such as ISO 15223-1 under the same conditions, including the symbols glossary.
Which edition of ISO 15223-1 does FDA recognize?
FDA recognizes ISO 15223-1:2021 (Recognition No. 5-134). FDA has listed a newer recognition including Amendment 1:2025 (No. 5-148) and will accept declarations of conformity to 5-134 in premarket submissions until December 17, 2028.
Sources
- 21 CFR 801.15 — Use of symbols in device labeling (Cornell LII)
- Federal Register, June 15, 2016 — Use of Symbols in Labeling (final rule)
- FDA — Use of Symbols in Labeling: Frequently Asked Questions
- FDA Recognized Consensus Standards — ISO 15223-1:2021, Recognition No. 5-134
- FDA — Device Labeling
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.