The symbol skips text. The glossary can't.

Open the instructions for use on almost any device cleared in the last decade and the symbols arrive before the words do — a sterilization icon, a single-use icon, a temperature range, a CE-style pictograph. None of them carry an English caption sitting next to them anymore, and that is not an oversight. It is a specific rule FDA wrote in 2016, and the rule has a half that most labeling reviews never get to: the symbol can skip the text. The glossary that explains it cannot.

The rule that let the text go

Before September 2016, a symbol in device labeling needed explanatory English text printed next to it — the pictograph alone was not a compliant label. FDA’s final rule, Use of Symbols in Labeling (81 FR 38911, June 15, 2016, amending 21 CFR parts 660, 801, and 809), removed that requirement under conditions it wrote into 21 CFR 801.15. A symbol drawn from a standard FDA has formally recognized under section 514(c) of the FD&C Act can stand alone, used exactly as that standard specifies. A symbol from anywhere else can still stand alone, but only on the manufacturer’s own documented judgment that an ordinary user is likely to understand it without accompanying words.

The half of the rule that didn’t move

Either way, 801.15 keeps one requirement fixed: the symbol still has to be explained somewhere, in a symbols glossary included in the device’s labeling, on paper or electronic. And separately, the labeling on or within the package has to carry its own prominent, conspicuous statement saying where that glossary is — and that statement itself has to be in English, with a narrow exception for products distributed only in Puerto Rico or a territory where English is not the predominant language. Dropping the caption next to the symbol was the point of the 2016 rule. Dropping the pointer to the glossary was never on the table.

Why this is easy to get backwards

The failure mode is rarely skipping the glossary outright — a labeling team that adopts a standalone symbol set usually knows a glossary has to exist somewhere in the IFU. It is treating the glossary’s existence as the whole obligation and losing track of the second, independent requirement: a statement on the label itself, prominent enough that a reader actually notices it, pointing to where the glossary lives. A glossary buried three pages into an instructions-for-use booklet a user may never open satisfies the first half of 801.15 and not the second. The regulation asks for two things, not one, and the second is the part a review checklist built around “do we have a glossary” tends to miss.

The symbol can speak for itself. The label still has to say, in English, where to find the sentence that explains it.

The practice

Before clearing a labeling redesign that drops English captions in favor of a standalone symbol set, check both ends of 801.15 independently: is each individual symbol either drawn from an FDA-recognized standard and used as specified, or separately justified as likely to be understood on its own — and does the package labeling itself, not just the IFU buried inside the carton, carry the English statement pointing to the glossary. Treating those as two separate sign-offs rather than one is not redundancy; it is the rule doing what the rule actually asks.

This is regulatory intelligence and method, not a determination about any specific label — whether a given symbol or a given statement satisfies 801.15 for a given device is a call for your regulatory and labeling team, reading the actual labeling against the actual rule.