Regulatory Open Forum

FDA currently dictates requirements for Medical Device labeling in 21 CFR 801.15 and states that “All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language", The interpretation is that every symbol must be accompanied by English text around the symbol on the Product label. The exception to this is for

1. The 24 symbols as identified in the OIVD guidance document of 2004 which allows use of only symbols in place of text. 
2. Rx guidance document of 2000 which allows use of Rx only as an alternative to prescription device labeling statement

In the EU, symbols are permitted under the usage of ISO 15223-1; which essential allows for use of harmonized symbols in countries and requires defining symbols in the IFU if not harmonized. There are some countries that recognize this ISO standard, but do state that anywhere there is English text it must be translated into their local language. This is one of the reasons that it is difficult to globalize labeling and companies often split between US & OUS labels.

On doing some research, I found that there was some draft guidance which would allow the use of FDA recognized symbols without adjacent text provided a glossary explaining the symbol meaning is provided. (Reference: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm350746.htm).

I was curious to know if anyone has heard about any update to FDA's draft guidance for allowing to have standalone harmonized symbols on the product labels? If not then can anyone share their experience if they have leveraged the draft guidance to create global labeling? 

------------------------------
Shiven Gandhi
San Francisco
------------------------------

FDA currently dictates requirements for Medical Device labeling in 21 CFR 801.15 and states that “All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language", The interpretation is that every symbol must be accompanied by English text around the symbol on the Product label. The exception to this is for

1. The 24 symbols as identified in the OIVD guidance document of 2004 which allows use of only symbols in place of text. 
2. Rx guidance document of 2000 which allows use of Rx only as an alternative to prescription device labeling statement

In the EU, symbols are permitted under the usage of ISO 15223-1; which essential allows for use of harmonized symbols in countries and requires defining symbols in the IFU if not harmonized. There are some countries that recognize this ISO standard, but do state that anywhere there is English text it must be translated into their local language. This is one of the reasons that it is difficult to globalize labeling and companies often split between US & OUS labels.

On doing some research, I found that there was some draft guidance which would allow the use of FDA recognized symbols without adjacent text provided a glossary explaining the symbol meaning is provided. (Reference: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm350746.htm).

I was curious to know if anyone has heard about any update to FDA's draft guidance for allowing to have standalone harmonized symbols on the product labels? If not then can anyone share their experience if they have leveraged the draft guidance to create global labeling? 

------------------------------
Shiven Gandhi
San Francisco
------------------------------

FDA currently dictates requirements for Medical Device labeling in 21 CFR 801.15 and states that “All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language", The interpretation is that every symbol must be accompanied by English text around the symbol on the Product label. The exception to this is for

1. The 24 symbols as identified in the OIVD guidance document of 2004 which allows use of only symbols in place of text. 


2. Rx guidance document of 2000 which allows use of Rx only as an alternative to prescription device labeling statement

In the EU, symbols are permitted under the usage of ISO 15223-1; which essential allows for use of harmonized symbols in countries and requires defining symbols in the IFU if not harmonized. There are some countries that recognize this ISO standard, but do state that anywhere there is English text it must be translated into their local language. This is one of the reasons that it is difficult to globalize labeling and companies often split between US & OUS labels.

On doing some research, I found that there was some draft guidance which would allow the use of FDA recognized symbols without adjacent text provided a glossary explaining the symbol meaning is provided. (Reference: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm350746.htm).

I was curious to know if anyone has heard about any update to FDA's draft guidance for allowing to have standalone harmonized symbols on the product labels? If not then can anyone share their experience if they have leveraged the draft guidance to create global labeling? 

------------------------------
Shiven Gandhi
San Francisco
------------------------------

FDA currently dictates requirements for Medical Device labeling in 21 CFR 801.15 and states that “All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language", The interpretation is that every symbol must be accompanied by English text around the symbol on the Product label. The exception to this is for

1. The 24 symbols as identified in the OIVD guidance document of 2004 which allows use of only symbols in place of text. 


2. Rx guidance document of 2000 which allows use of Rx only as an alternative to prescription device labeling statement

In the EU, symbols are permitted under the usage of ISO 15223-1; which essential allows for use of harmonized symbols in countries and requires defining symbols in the IFU if not harmonized. There are some countries that recognize this ISO standard, but do state that anywhere there is English text it must be translated into their local language. This is one of the reasons that it is difficult to globalize labeling and companies often split between US & OUS labels.

On doing some research, I found that there was some draft guidance which would allow the use of FDA recognized symbols without adjacent text provided a glossary explaining the symbol meaning is provided. (Reference: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm350746.htm).

I was curious to know if anyone has heard about any update to FDA's draft guidance for allowing to have standalone harmonized symbols on the product labels? If not then can anyone share their experience if they have leveraged the draft guidance to create global labeling? 

------------------------------
Shiven Gandhi
San Francisco
------------------------------

Hello All,

Thank you for your comments/feedback.

With regards to Robert's and Sam's comment- ISO 15223 is a FDA recognized standard, however we still need to add text next to those symbols and also per the proposed rule, will need to provide a symbol glossary in the Instruction for Use (IFU)?

Sam,  based on the petition you shared (Ref: http://medicaldevicesip.com/wp-content/uploads/2015/10/View-Attachment-PDF19.pdf), it seems that FDA still needs descriptors (text) with symbols. Do you know if there was any update to the petition which was filed in October 2015?

@Ginger: Can you share other countries apart from US which require text next to Symbols? I am aware that certain EU countries need the text translated in local language but that it only if you have some text with the symbols.

Any suggestion on how one can leverage this draft guidance by engaging FDA buy-in (example: pre-sub, etc.) OR any alternative ways to move the proposed rule forward? 

Thank you

Hello Shiven,

FDA currently dictates requirements for Medical Device labeling in 21 CFR 801.15 and states that “All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language", The interpretation is that every symbol must be accompanied by English text around the symbol on the Product label. The exception to this is for

1. The 24 symbols as identified in the OIVD guidance document of 2004 which allows use of only symbols in place of text. 
2. Rx guidance document of 2000 which allows use of Rx only as an alternative to prescription device labeling statement

In the EU, symbols are permitted under the usage of ISO 15223-1; which essential allows for use of harmonized symbols in countries and requires defining symbols in the IFU if not harmonized. There are some countries that recognize this ISO standard, but do state that anywhere there is English text it must be translated into their local language. This is one of the reasons that it is difficult to globalize labeling and companies often split between US & OUS labels.

On doing some research, I found that there was some draft guidance which would allow the use of FDA recognized symbols without adjacent text provided a glossary explaining the symbol meaning is provided. (Reference: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm350746.htm).

I was curious to know if anyone has heard about any update to FDA's draft guidance for allowing to have standalone harmonized symbols on the product labels? If not then can anyone share their experience if they have leveraged the draft guidance to create global labeling? 

------------------------------
Shiven Gandhi
San Francisco
------------------------------

FDA currently dictates requirements for Medical Device labeling in 21 CFR 801.15 and states that “All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language", The interpretation is that every symbol must be accompanied by English text around the symbol on the Product label. The exception to this is for

1. The 24 symbols as identified in the OIVD guidance document of 2004 which allows use of only symbols in place of text. 


2. Rx guidance document of 2000 which allows use of Rx only as an alternative to prescription device labeling statement

In the EU, symbols are permitted under the usage of ISO 15223-1; which essential allows for use of harmonized symbols in countries and requires defining symbols in the IFU if not harmonized. There are some countries that recognize this ISO standard, but do state that anywhere there is English text it must be translated into their local language. This is one of the reasons that it is difficult to globalize labeling and companies often split between US & OUS labels.

On doing some research, I found that there was some draft guidance which would allow the use of FDA recognized symbols without adjacent text provided a glossary explaining the symbol meaning is provided. (Reference: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm350746.htm).

I was curious to know if anyone has heard about any update to FDA's draft guidance for allowing to have standalone harmonized symbols on the product labels? If not then can anyone share their experience if they have leveraged the draft guidance to create global labeling? 

------------------------------
Shiven Gandhi
San Francisco
------------------------------

Interestingly, it seems FDA intends to issue this final rule in the next few days: see Unified Agenda-TRACK (search "Within 30 days" and the search time "labeling").

Interestingly, it seems FDA intends to issue this final rule in the next few days: see Unified Agenda-TRACK (search "Within 30 days" and the search time "labeling").

Hi Jennifer,

Do you know if they had a final rule published regarding the 'Use of Certain Symbols in Labeling'? I could not find anything and the date on the system shows it was released on 3/31/2016.

Thank you

Shiven

Hi Shiven,

It looks like no final rule has been published yet - see here. It still shows as a target date of March (03/00/2016), which may be why it no longer shows up in the search of what's coming in the next while. 

It's never a surprise when things take longer than expected, but hopefully having a target date assigned means it won't take too much longer!

Jennifer

Hi Jennifer,

Do you know if they had a final rule published regarding the 'Use of Certain Symbols in Labeling'? I could not find anything and the date on the system shows it was released on 3/31/2016.

Thank you

Shiven

Hello everyone,

I am following up on the original thread to see if there has been any recent updates. I am particularly interested in the following case:

Say, the medical device has a Software User Interface where the manufacturer uses custom symbols. Is it sufficient to describe/define these symbols in the IFU or is there a need to place said text immediately adjacent to the symbol in the User Interface? 

My clarification is in the context of US FDA but would love to hear about your experience in other jurisdictions as well.

Cheers

Thas

Hi Shiven,

It looks like no final rule has been published yet - see here. It still shows as a target date of March (03/00/2016), which may be why it no longer shows up in the search of what's coming in the next while. 

It's never a surprise when things take longer than expected, but hopefully having a target date assigned means it won't take too much longer!

Jennifer

Hi Jennifer,

Do you know if they had a final rule published regarding the 'Use of Certain Symbols in Labeling'? I could not find anything and the date on the system shows it was released on 3/31/2016.

Thank you

Shiven

One of the purposes of the new regulation is to harmonize the US device labeling requirements with international regulatory requirements. The FDA currently recognizes a list of standards that contain a limited number of stand-alone symbols. These standards are: 

• ISO & ANSI/AAMI/ISO 27185 - Symbols to be used with cardiac rhythm management device labels
• ISO & ANSI/AAMI/ISO 15223-1 - Medical devices—Symbols to be used with medical devices labels - General requirements
• ASTM F2503-13 - Standard Practice For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment
• IEC 60417:2002 DB - Graphical symbols for use on equipment
• ISO 7000: Fifth edition 2014/01/15 - Graphical symbols for use on equipment – Registered symbols
• IEC/TR 60878 Ed. 3.0 b:2015 - Graphical symbols for electrical equipment in medical practice

The regulation allows for manufacturers to use standardized symbols without adjacent explanatory text (“stand-alone symbols”) but states manufacturers may also opt to use symbols accompanied by adjacent explanatory text or no symbols at all. This leaves three options for the use of symbols:

• no use of symbols,
• use of symbols with explanatory text, or
• use of stand-alone symbols from a Standards Development Organization (SDO) standard with a symbols glossary
  • Whenever symbols are used, a symbols glossary is required to be included in the labeling (i.e. IFU), but may be provided in paper or electronic format.

"Custom Symbols" are not prohibited for use by either the US or the EU; but they either need to be approved and added to one of the recognized standards, or have accompanying explanatory text. 

The ISO standard for developing new symbols is ISO 15223-2:2010 - Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation.  

Hello everyone,

I am following up on the original thread to see if there has been any recent updates. I am particularly interested in the following case:

Say, the medical device has a Software User Interface where the manufacturer uses custom symbols. Is it sufficient to describe/define these symbols in the IFU or is there a need to place said text immediately adjacent to the symbol in the User Interface? 

My clarification is in the context of US FDA but would love to hear about your experience in other jurisdictions as well.

Cheers

Thas

Hi Shiven,

It looks like no final rule has been published yet - see here. It still shows as a target date of March (03/00/2016), which may be why it no longer shows up in the search of what's coming in the next while. 

It's never a surprise when things take longer than expected, but hopefully having a target date assigned means it won't take too much longer!

Jennifer

Hi Jennifer,

Do you know if they had a final rule published regarding the 'Use of Certain Symbols in Labeling'? I could not find anything and the date on the system shows it was released on 3/31/2016.

Thank you

Shiven

I agree that the custom symbols in the software user interface require adjacent explanatory text.   If the symbol is related to an action (e.g. On-screen button) perhaps that explanatory text can be made to appear when the cursor hovers over the button. 

One of the purposes of the new regulation is to harmonize the US device labeling requirements with international regulatory requirements. The FDA currently recognizes a list of standards that contain a limited number of stand-alone symbols. These standards are: 

• ISO & ANSI/AAMI/ISO 27185 - Symbols to be used with cardiac rhythm management device labels
• ISO & ANSI/AAMI/ISO 15223-1 - Medical devices—Symbols to be used with medical devices labels - General requirements
• ASTM F2503-13 - Standard Practice For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment
• IEC 60417:2002 DB - Graphical symbols for use on equipment
• ISO 7000: Fifth edition 2014/01/15 - Graphical symbols for use on equipment – Registered symbols
• IEC/TR 60878 Ed. 3.0 b:2015 - Graphical symbols for electrical equipment in medical practice

The regulation allows for manufacturers to use standardized symbols without adjacent explanatory text (“stand-alone symbols”) but states manufacturers may also opt to use symbols accompanied by adjacent explanatory text or no symbols at all. This leaves three options for the use of symbols:

• no use of symbols,
• use of symbols with explanatory text, or
• use of stand-alone symbols from a Standards Development Organization (SDO) standard with a symbols glossary
  • Whenever symbols are used, a symbols glossary is required to be included in the labeling (i.e. IFU), but may be provided in paper or electronic format.

"Custom Symbols" are not prohibited for use by either the US or the EU; but they either need to be approved and added to one of the recognized standards, or have accompanying explanatory text. 

The ISO standard for developing new symbols is ISO 15223-2:2010 - Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation.  

Hello everyone,

I am following up on the original thread to see if there has been any recent updates. I am particularly interested in the following case:

Say, the medical device has a Software User Interface where the manufacturer uses custom symbols. Is it sufficient to describe/define these symbols in the IFU or is there a need to place said text immediately adjacent to the symbol in the User Interface? 

My clarification is in the context of US FDA but would love to hear about your experience in other jurisdictions as well.

Cheers

Thas

Hi Shiven,

It looks like no final rule has been published yet - see here. It still shows as a target date of March (03/00/2016), which may be why it no longer shows up in the search of what's coming in the next while. 

It's never a surprise when things take longer than expected, but hopefully having a target date assigned means it won't take too much longer!

Jennifer

Hi Jennifer,

Do you know if they had a final rule published regarding the 'Use of Certain Symbols in Labeling'? I could not find anything and the date on the system shows it was released on 3/31/2016.

Thank you

Shiven

I agree that the custom symbols in the software user interface require adjacent explanatory text.   If the symbol is related to an action (e.g. On-screen button) perhaps that explanatory text can be made to appear when the cursor hovers over the button. 

One of the purposes of the new regulation is to harmonize the US device labeling requirements with international regulatory requirements. The FDA currently recognizes a list of standards that contain a limited number of stand-alone symbols. These standards are: 

• ISO & ANSI/AAMI/ISO 27185 - Symbols to be used with cardiac rhythm management device labels
• ISO & ANSI/AAMI/ISO 15223-1 - Medical devices—Symbols to be used with medical devices labels - General requirements
• ASTM F2503-13 - Standard Practice For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment
• IEC 60417:2002 DB - Graphical symbols for use on equipment
• ISO 7000: Fifth edition 2014/01/15 - Graphical symbols for use on equipment – Registered symbols
• IEC/TR 60878 Ed. 3.0 b:2015 - Graphical symbols for electrical equipment in medical practice

The regulation allows for manufacturers to use standardized symbols without adjacent explanatory text (“stand-alone symbols”) but states manufacturers may also opt to use symbols accompanied by adjacent explanatory text or no symbols at all. This leaves three options for the use of symbols:

• no use of symbols,
• use of symbols with explanatory text, or
• use of stand-alone symbols from a Standards Development Organization (SDO) standard with a symbols glossary
  • Whenever symbols are used, a symbols glossary is required to be included in the labeling (i.e. IFU), but may be provided in paper or electronic format.

"Custom Symbols" are not prohibited for use by either the US or the EU; but they either need to be approved and added to one of the recognized standards, or have accompanying explanatory text. 

The ISO standard for developing new symbols is ISO 15223-2:2010 - Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation.  

Hello everyone,

I am following up on the original thread to see if there has been any recent updates. I am particularly interested in the following case:

Say, the medical device has a Software User Interface where the manufacturer uses custom symbols. Is it sufficient to describe/define these symbols in the IFU or is there a need to place said text immediately adjacent to the symbol in the User Interface? 

My clarification is in the context of US FDA but would love to hear about your experience in other jurisdictions as well.

Cheers

Thas

Hi Shiven,

It looks like no final rule has been published yet - see here. It still shows as a target date of March (03/00/2016), which may be why it no longer shows up in the search of what's coming in the next while. 

It's never a surprise when things take longer than expected, but hopefully having a target date assigned means it won't take too much longer!

Jennifer

Hi Jennifer,

Do you know if they had a final rule published regarding the 'Use of Certain Symbols in Labeling'? I could not find anything and the date on the system shows it was released on 3/31/2016.

Thank you

Shiven

Thank you Lena and Diane.

You stated: ""Custom Symbols" are not prohibited for use by either the US or the EU; but they either need to be approved and added to one of the recognized standards, or have accompanying explanatory text. "

Are the standards implying that accompanying explanatory text has to be present in the Software UI itself (i.e. place the text adjacent to icon in the UI or as 'pop up') or can the explanation be provided in the IFU alone?

I can definitely see the importance of explaining the role of the icons in the IFU; however, I am struggling with adding text within the software UI for functional icons that do not have a hazardous situation associated with them.

Thanks.

Thas 

I agree that the custom symbols in the software user interface require adjacent explanatory text.   If the symbol is related to an action (e.g. On-screen button) perhaps that explanatory text can be made to appear when the cursor hovers over the button. 

One of the purposes of the new regulation is to harmonize the US device labeling requirements with international regulatory requirements. The FDA currently recognizes a list of standards that contain a limited number of stand-alone symbols. These standards are: 

• ISO & ANSI/AAMI/ISO 27185 - Symbols to be used with cardiac rhythm management device labels
• ISO & ANSI/AAMI/ISO 15223-1 - Medical devices—Symbols to be used with medical devices labels - General requirements
• ASTM F2503-13 - Standard Practice For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment
• IEC 60417:2002 DB - Graphical symbols for use on equipment
• ISO 7000: Fifth edition 2014/01/15 - Graphical symbols for use on equipment – Registered symbols
• IEC/TR 60878 Ed. 3.0 b:2015 - Graphical symbols for electrical equipment in medical practice

The regulation allows for manufacturers to use standardized symbols without adjacent explanatory text (“stand-alone symbols”) but states manufacturers may also opt to use symbols accompanied by adjacent explanatory text or no symbols at all. This leaves three options for the use of symbols:

• no use of symbols,
• use of symbols with explanatory text, or
• use of stand-alone symbols from a Standards Development Organization (SDO) standard with a symbols glossary
  • Whenever symbols are used, a symbols glossary is required to be included in the labeling (i.e. IFU), but may be provided in paper or electronic format.

"Custom Symbols" are not prohibited for use by either the US or the EU; but they either need to be approved and added to one of the recognized standards, or have accompanying explanatory text. 

The ISO standard for developing new symbols is ISO 15223-2:2010 - Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation.  

Hello everyone,

I am following up on the original thread to see if there has been any recent updates. I am particularly interested in the following case:

Say, the medical device has a Software User Interface where the manufacturer uses custom symbols. Is it sufficient to describe/define these symbols in the IFU or is there a need to place said text immediately adjacent to the symbol in the User Interface? 

My clarification is in the context of US FDA but would love to hear about your experience in other jurisdictions as well.

Cheers

Thas

Hi Shiven,

It looks like no final rule has been published yet - see here. It still shows as a target date of March (03/00/2016), which may be why it no longer shows up in the search of what's coming in the next while. 

It's never a surprise when things take longer than expected, but hopefully having a target date assigned means it won't take too much longer!

Jennifer

Hi Jennifer,

Do you know if they had a final rule published regarding the 'Use of Certain Symbols in Labeling'? I could not find anything and the date on the system shows it was released on 3/31/2016.

Thank you

Shiven