For years, medical device manufacturers have had to take two approaches to labelling. In the US, FDA have insisted that symbols are accompanied by words to describe their meaning, whereas most of the rest of the world has been happy to use symbols alone. This means US labels are necessarily more complex, and some would argue, less effective. The insistence on wording was argued to be required in order to avoid doubt as to the meaning of the symbol;. In effect this old approach effectively makes the symbol redundant.
All this is about to change as FDA finally embraces the use of stand alone standardised symbols. Today FDA is scheduled to publish its Final Rule on use of symbols in device labelling. If all goes to plan the rule will be come effective in 90 days – on 13 September, 2016.
The rule modifies parts of 21 CFR part 600 and 801 (respectively biologics and devices labelling reporting and record keeping requirements ) and 809 (devices labelling). The primary effect of the change is to allow a manufacturer to use standardised symbols in place of text on product labelling. FDA is introducing a change to its recognised standards list (See list below) to endorse the international medical devices labelling standard ISO 15523 as well as several product specific labelling standards covering pacemakers, electrical equipment generally and symbols relating to MRI safety. Cruciallly FDA goes further than this. The final rule allows use of symbols from ANY standard produced by a Standards Development Organisation even if that standard (or part of the standard containing the symbol) is not formally recognised by FDA. Inthe use of non-recognised standards FDA does expect the symbol to be used in compliance with the requirements of the source standard, or for the manufacturer to be able to justify any deviations from such requirements. The key test is “that the manufacturer determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act and uses the symbol according to the specifications for use of the symbol set forth in the SDO-developed standard”. In simple terms – use symbols from standards according to the requirements of the standard and you should be in compliance.
Additions to FDA’s List of Recognised Standards
ISO 27185: 2012, Cardiac rhythm management devices – symbols to be used with cardiac rhythm management device labels, and information to be supplied – general requirements
ISO 15223-1: 2012, Medical devices – symbols to be used with medical device labels, labelling, and information to be supplied – Part 1: general requirements.
ASTM F2503-13 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
IEC 60417: 2002 Graphical symbols for use on equipment
ISO 7000: 2014 Graphical symbols for use on equipment – Registered symbols
IEC/TR 60878: 2015 Graphical symbols for electrical equipment in medical practice
The change doesn’t completely abandon the use of written descriptions. Manufacturers will still have to explain the symbols. However the explanations no longer have to appear on labelling next to the symbol. Instead, the explanations may now be provided in a separate glossary of symbols, provided either printed glossary in the user manual or as a separate leaflet with the device or as an electronic glossary – which could mot easilty be maintained by publication on a web page with a link printed on the labelling.
In simple terms – use symbols from standards according to the requirements of the standard and you should be in compliance.
It’s notable that this approach to symbols has been normal practice for US marketed IVDs for some years. This is really a catch up for the rest of devices. FDA intends to withdraw the IVD Symbols Guidance on finalisation of the new rule.
Implications for manufacturers:
If you have a device currently marketed and labelled – there’s no need to do anything. FDA has made it clear that manufacturers can continue as usual with currently valid labelling, words and all. If a manufacturer wishes to transition to symbols only, that’s possible without any need to submit the new labelling for regulatory review providing:
- the change in labelling uses symbols from the recognised standards list or another SDO developed standard and
- the removal of the words does not result in any change in labelling meaning.
Come 13 September, manufacturers bringing forward new regulatory submissions can prepare draft labelling using symbols only as per the new rule. Once the Final rule is published it would be expected that all current and future submissions would be able to take the new approach in anticipation of the implementation of the rule change in September.
Click here for the full FDA recognised standards database.
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