Final rule on use of symbols on labeling - Symbols without text under some conditions

[Marcelo]

The FDA finally published the revised rule on use of symbols on labeling, enabling symbols without accompanying text under certain conditions.

Final rule - https://goo.gl/6TX5j7

Revised standards recognition - https://goo.gl/1EsIHl

 

[Pads38]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

Thanks Marcelo, that will likely be useful.

One thing I noted was that, in common with European requirements, a listing of symbols used with explanation is required in the Instructions for Use. But it also demands that the source of such symbols is included.

(B) The term “symbols glossary” means a compiled listing of:
(1) Each SDO-established symbol used in the labeling for the device;
(2) The title and designation number of the SDO-developed standard containing the symbol;
(3) The title of the symbol and its reference number, if any, in the standard;

(Page 76 of Marcelo's linked document)

 

[Marcelo]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

Thanks Marcelo, that will likely be useful.

One thing I noted was that, in common with European requirements, a listing of symbols used with explanation is required in the Instructions for Use. But it also demands that the source of such symbols is included.
Quote:
(B) The term “symbols glossary” means a compiled listing of:
(1) Each SDO-established symbol used in the labeling for the device;
(2) The title and designation number of the SDO-developed standard containing the symbol;
(3) The title of the symbol and its reference number, if any, in the standard;
(Page 76 of Marcelo's linked document)

Yes, that's because, to have this rule accepted, the compromise was that only "validated"symbols (or something like that) would be accepted. That's why we created ISO 15223-1, and, in particular, ISO 15223-2 (to have a formal process to validate symbols). So, it's required to made it clear that the symbols use the sources that are acceptable.

 

[Ronen E]

FDA issues final rule on use of symbols in labeling

Today the Food and Drug Administration (FDA) issued a final rule “Use of Symbols in Labeling” allowing the use of stand-alone symbols in medical device labeling, without adjacent explanatory text. The final rule seeks to harmonize the labeling requirements of U.S. and international regulatory bodies with respect to the use of symbols in device labeling.

This final rule is revising the medical device and certain biological product labeling regulations by explicitly allowing graphical representation of information (symbols) in labeling (including labels) without adjacent explanatory text (“stand-alone symbols”). A stand-alone symbol can be used if the symbol has been established as part of a standard developed by a national or international standards development organization (SDO) (referred to as a “standardized symbol”) and such standardized symbol is authorized for stand-alone use in labeling as part of a standard when a symbols glossary is included in the labeling for the medical device.

The FDA also published a new standards-recognition notice that modifies the Agency’s current list of recognized standards containing stand-alone symbols to extend the recognition of six standards and to recognize three new consensus standards containing many more stand-alone symbols.

Ronen.

 

[MIREGMGR]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

This provides no benefit for devices that aren't required to have, and don't have, an IFU.

Title 21, Chapter 9, Subchapter V, Part A of the United States Code--the Federal Food, Drug and Cosmetic Act—requires that all medical devices be properly labeled, including “adequate directions for use”.

21 CFR 801 “Labeling”, Subpart A, Section 801.5 “Medical Devices—Adequate
Directions for Use”, defines this term to mean “directions under which the layman can use a device safely and for the purposes for which it is intended.”

Some simple devices of course can have adequate directions for use on the primary label, but that's not practical if the device is even moderately complicated. Inclusion of an IFU with the device is a common way to meet this requirement for the latter kind of devices.

21 CFR 801.109 exempts from the above requirement a device that cannot be used “safely” by a lay individual not under the supervision of a licensed practitioner, if the device in question is sold only to appropriate users (typically, professionals or clinically trained individuals); the device’s labeling includes adequate directions for use by personnel under the supervision of a licensed practitioner, or the device is such that methods of use are commonly known to the above personnel; and the device’s labeling includes a “prescription only” statement.

We make hundreds of types of professional-use-only, Rx-only, well-understood-application disposables for use in hospitals, that don't have IFUs. Unless FDA clarifies that we can publish an electronic glossary online, we appear unlikely to benefit from the change.

 

[katastic2908]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

Hello, I am in need of clarification or guidance on the FDA's ruling.

I understand we can use standardized symbols that are contained in the approved list of standards without additional text providing we have Glossary of the used symbols in the IFU (for example) and we reference what standard the symbol is in, am I correct so far?

What I am confused about is if we use a symbol that isn't in a standard, one that we developed, if we validated that symbol using 15223-2, can we continue to use that symbol in labels, without text, if we also reference it the Glossary of symbols in our IFU? If this is allowed, what if we also included the appropriate symbol to indicate "consult instructions for use" with our validated symbols?

My example is, we have a product that is battery operated and has indicator lights that alert the user that the battery ok, or the battery is low, there is another indicator light to alert the user there is a problem (either dead battery, or other malfunction). Located on the device is a tag, the tag has a "green check mark", this green check mark looks the same as one of the indicator lights on the device (the indicator light is a green check mark), on the tag the green check mark is followed by the word "OK", another symbol the tag has is "green check mark with lines around it symbolizing a flashing light" next to that symbol is an equal sign and a depiction of a low battery" this is to indicate the device is ok to use, but beware it has a low battery. The tag also has a "red X", one of the indicator lights on the device is a "red X", next to the red X is the blue man symbol used in 60601 to consult the IFU/service manual. The tag was validated and shown that the symbols were easy to understand by the user. We have included the symbols in our glossary of symbols located in the Service Manual.

I'm wondering if the tag qualifies as a label (I figured it was, but I was just checking), and if the "Green check mark" and "Red X" qualify as symbols since they are a replica of the indicator lights that are used on the device, and since we validated the tag can we continue to use the symbols on it as stand alone symbols. TIA

 

[Ronen E]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

I'm wondering if the tag qualifies as a label (I figured it was, but I was just checking), and if the "Green check mark" and "Red X" qualify as symbols since they are a replica of the indicator lights that are used on the device, and since we validated the tag can we continue to use the symbols on it as stand alone symbols. TIA

Hello Katastic and welcome to the Cove

Yes, the tag would be labeling, and yes, in my opinion the green check mark and red X would conservatively be considered symbols.

Based on my reading of the new rule as published in the FR, what you describe you intend to do is acceptable. My understanding is that symbols that are not included in a recognized standard can be used under certain conditions. I'm yet to read the updated part 801 (Lebeling) text based on the new rule. Hopefully that would clarify the most current Do's and Don't's.

Cheers,
Ronen.

 

[katastic2908]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

Hello,

I was wondering if anyone had a sample Glossary tha would be acceptable. I am still a little confused and want to make sure I do it correctly. Or I could show you the glossary we came up with and you can tell me if you think it is acceptable. Thank you

 

[image182]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

I have a quick question on this which relates to the requirements of the symbols glossary. The updated 801.15(c)(1)(iii)(B)(4)

(B) The term “symbols glossary” means a compiled listing of:

1. Each SDO-established symbol used in the labeling for the device;
2. The title and designation number of the SDO-developed standard containing the symbol;
3. The title of the symbol and its reference number, if any, in the standard; and
4. The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.

Option 1

• We place a "symbol with explanatory text" on the carton

Option 2

• We place a "symbol only" on the carton
• We place a statement on the carton which refers the user to the IFU
• We place a symbols glossary in the IFU which contains the "symbol with explanatory text"
• We place a symbols glossary in the IFU which explains what standard every symbol came from

At present we are complaint with Option 2 except for the fact that we don't explain what standard each symbol came from.

Would it be true that our labeling would now be non-complaint because of this?

I find it confusing why this would be true, since there is no requirement to reference any ISO standards if we were to use Option 1.

Has anybody else found themselves in a similar situation?

 

[QA-Man]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

We're doing Option 3: We're placing a human readable URL with QR code that goes to a symbol glossary page on our website.