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General labeling information, not medical advice. For a specific product, the manufacturer’s instructions for use govern.
Short answer
The date of manufacture symbol is a label symbol that marks the date a device was made, shown next to a date. It is not an expiration date: US rules treat the date of manufacture and the expiration date as separate dates a label may carry, and a manufacture date alone does not tell you how long a product stays usable.
Definition and scope
On medical and laboratory supply packaging, symbols stand in for words so one label can serve many markets. The date of manufacture symbol sits beside a printed date and says that date is when the item was made. For other medical device label symbols, see ISO 15223-1 medical device symbols. This page covers only what the symbol and its date mean and how US labeling rules treat them.
How the symbol and its date are used on labels
When a symbol may stand without words (US)
Under 21 CFR 801.15(c), one route lets a symbol appear without adjacent explanatory text: the symbol is established in a standard developed by a standards development organization, is used according to that standard, and is explained in a paper or electronic symbols glossary included in the labeling for the device (801.15(c)(1)(i)(E)). A symbols glossary is a compiled listing of each such symbol used in the labeling. Using a symbol that does not meet the requirements of 801.15(c)(1)(i) makes the device misbranded. This is why many product inserts carry a symbol key: the glossary is part of what makes a bare symbol acceptable.
How the date itself is written (US)
21 CFR 801.18 applies whenever a device label includes a printed expiration date, date of manufacture, or any other date meant for the user’s attention. The date must use a four-digit year, a two-digit month and a two-digit day, separated by hyphens. January 2, 2014 is written 2014-01-02. The rule has exceptions: a combination product that properly bears a National Drug Code number is not subject to it, and certain electronic products follow 21 CFR 1010.3(a)(2)(ii).
Where it appears in a UDI
Under 21 CFR 801.40, if a device label includes a lot or batch number, a serial number, a manufacturing date or an expiration date, the unique device identifier must include a production identifier segment that conveys that information. See unique device identification for how the identifier is built.
Related label dates and identifiers
The regulation names four separate items a label may carry, and each answers a different question:
- Date of manufacture: when the item was made.
- Expiration date: the date by which the label of a device states the device must or should be used (21 CFR 801.3). Both dates fall under the same 801.18 format rule.
- Lot or batch number: which production run the item came from. See lot number.
- Serial number: which individual unit it is.
For other symbols printed alongside these, such as single use or keep dry, read the manufacturer’s symbols key in the labeling; for a worked example of a symbol glossary on one product family see AED symbols.
Where it matters for labs and clinics
A receiving check can use the facts above. Because the UDI production identifier carries whichever of these items the label shows, the label’s own printed dates and numbers are the traceability data a lab or clinic can log on receipt: lot or batch number, serial number, date of manufacture and expiration date, wherever the label shows them. Whether a given product shows all four is set by the manufacturer, not by a universal rule.
Common misunderstandings
- “Manufacture date means expiry.” The regulation lists them as distinct dates. Use the expiration date the label states, and the manufacturer’s instructions for any shelf-life question.
- “Any picture works as a symbol.” Under 21 CFR 801.15(c)(1)(i)(E), a symbol used without text is tied to a standard and explained in a glossary in the labeling.
- “Dates can be written any way.” Where 801.18 applies, the format is year-month-day with hyphens, such as 2014-01-02.
FAQ
What does the date of manufacture symbol mean?
It marks the date shown beside it as the date the device was manufactured.
Is the date of manufacture the same as the expiration date?
No. 21 CFR 801.18 and 801.40 treat them as separate items a label may carry.
How should a manufacture date be formatted on a US device label?
Four-digit year, two-digit month, two-digit day, separated by hyphens, for example 2014-01-02, under 21 CFR 801.18.
Does the UDI include the manufacture date?
If the label includes a manufacturing date, the UDI must include a production identifier segment that conveys it (21 CFR 801.40).
Sources
- 21 CFR 801.15, Medical devices; prominence of required label statements; use of symbols in labeling. Cornell LII, https://www.law.cornell.edu/cfr/text/21/801.15, checked 2026-10-30.
- 21 CFR 801.18, Format of dates provided on a medical device label. Cornell LII, https://www.law.cornell.edu/cfr/text/21/801.18, checked 2026-10-30.
- 21 CFR 801.40, Form of a unique device identifier. Cornell LII, https://www.law.cornell.edu/cfr/text/21/801.40, checked 2026-10-30.
- 21 CFR 801.3, Definitions. Cornell LII, https://www.law.cornell.edu/cfr/text/21/801.3, checked 2026-10-30.
