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Reference Section

Labelling to Meet a Worldwide Need

a report by

Judi Smith

Principal, Sienna Partners LLC

The Global Labelling Issue

Proposed Solutions ­ Labels, Inventory and Symbols

Judi Smith is a principal of Sienna Partners LLC, a consulting firm specialising in regulatory, quality and manufacturing for the medical products industry. In her career, she has been responsible for regulatory submissions for in vitro diagnostic, medical device and biological products, and for drug and diagnostic products' quality systems. Ms Smith is regulatory affairs certified through the Regulatory Affairs Professionals Society and was recently awarded the US Food and Drug Administration (FDA) Group Recognition Award as a member of the FDA/Industry Roundtable. She is on the board of the Association of Medical Diagnostics Manufacturers and has also served on the in vitro diagnostic (IVD) and premarket approval application (PMA) taskforce committees of AdvaMed. Ms Smith received her Bachelor of Science degree from Temple University and her Masters of Science degree from the Medical College of Pennsylvania.

Medical device and in vitro diagnostic (IVD) manufacturers worldwide are now faced with the challenge of becoming `out-of-the-box' thinkers in a somewhat restricted arena ­ labelling. Manufacturers now need to develop labelling that meets all countries' labelling requirements yet fits on a small label and does not interfere with the performance of the device. Requirements for labelling in the US have been clearly defined in the US Food and Drug Administration (FDA) regulations (21 Code of Federal Regulations (CFR) 809.10) for many years. Until recently, labelling of medical device products in Europe was not as clearly defined, and differed from country to country. Adoption in the 1990s of the Medical Device Directive and the IVD Directive (IVDD) by the European Union, and subsequent transposition of these directives by the Member States into their national regulations, introduced consistency in product labelling. However, some of the transpositions included additional requirements for labelling; the one with the most impact was the requirement that labelling be in the national language of the territory in which the product is sold. The FDA regulations and European Union directives both define labelling as the labels on the product and the instructions for use (package inserts) that accompany the product. This means that the issue of languages and physical space apply to the labels and the inserts. In the past, medical device and IVD manufacturers who distributed their products worldwide usually provided the product labels and inserts in the four most common languages: English, French, Spanish and German. This sometimes offered some challenges with small products ­ the labels on the product were therefore small and the packaging did not permit the inclusion of thick inserts. Font sizes, colour-coding and abbreviations were implemented to address these early issues. With the introduction of Member State national language requirements, these initial `answers' no longer address the issue.

The question facing medical device manufacturers in the current global market is how they will meet all language requirements in the most cost-effective, regulatory-compliant way. This is where out-ofthe-box thinking is needed. There have been many interim solutions suggested while everyone struggles for the best out-of-the-box answer. One solution is to maintain at least three sets of inventory for the same product (assuming one set of labelling accommodates four languages and at least 12 national languages are needed). This certainly is the easiest to implement but represents logistical problems for production planning and inventory control personnel, concerning how much of each set should be manufactured and how back orders in one set are balanced against overproduction in another set. Another solution is to keep inventory unlabelled until an order is received and then label it according to the order's requirements. This is time-consuming, very expensive and has the potential for inventory discrepancies. A third solution is a combination of the first two ­ print three languages on the label and leave space for a fourth that is applied as a separate label at the time of the order. This offers better production planning and inventory control but does not remove the time and cost factors. The best solution to date is the use of symbols wherever feasible or possible. The Global Harmonization Task Force published a document on 24 February 2000 entitled Labelling for Medical Devices. In the document, they stated the following (among other recommendations): "The use of internationally recognized [sic] (i.e. standardised) symbols should be encouraged provided that device safety is not compromised by a lack of understanding on the part of the patient or user. Where the meaning of the symbol is not obvious to the device user (who, with some products, could be a member of the public), it should be described in words associated with the symbol."

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BUSINESS BRIEFING: MEDICAL DEVICE MANUFACTURING & TECHNOLOGY 2002

Labelling to Meet a Worldwide Need

The European IVDD (Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices) supports this recommendation. In Annex I, Section 8.2 of the document, it states: "Where appropriate, the information to be supplied should take the form of symbols. Any symbol and identification colour used must conform to the harmonized [sic] standards. In areas for which no standards exist, the symbols and colour used must be described in the documentation supplied with the device." The major hindrance to the worldwide implementation of symbols is the reluctance of the FDA to readily accept their use. Without FDA support of the concept, manufacturers, once again, will need to maintain two inventories ­ one for USdistributed products (containing no symbols) and a second for the rest of the world (containing symbols). The FDA's reluctance stems from two concerns: 1. the possible inability of the end-user or patient to understand the symbols, potentially resulting in unsafe and/or ineffective use of the product; and 2. the constraints of the US labelling regulations regarding words versus symbols.

Common and Intuitive Symbols

Figure 1: Proposed Symbols

`Use By' = expiration date

`Batch Code' = Lot number (reagent)

`Serial Number' (instrument)

Sterilised with ethylene oxide

Sterilised with radiation

Sterilised with steam or heat

Processed using aseptic technique

`Caution, Consult Accompanying Documents' = Attention, see instructions for use

`Manufacturer' = Name and address of the manufacturer adjacent to the symbol

`In Vitro Diagnostic Medical Device'

`Temperature Limitation' = Recommended product storage temperature range

`Consult Instructions for Use' = Refer to package insert

AdvaMed, the former Health Industry Manufacturers' Association, has been working with the FDA to address these two concerns relative to IVDs. With regard to the possible inability of the end-user to understand the symbols, AdvaMed has proposed that the symbols only be included in the labelling of products sold for professional use only. In addition, they suggest use of only the more common and intuitive symbols from EN 980:1996 "Graphic Symbols for Use in the Labelling of Medical Devices", with a legend or glossary of definitions included in the product's package insert. Figure 1 shows some of the proposed symbols. AdvaMed has mapped out an educational programme to train the laboratorians in the recognition of these symbols. These programmes include seminars at large laboratory association meetings and wallcharts for display in the laboratories to serve as reminders. Chemical symbols or abbreviations have been used for several years in place of the full word because these abbreviations are considered multilingual. Examples include NaCl in place of `sodium chloride', and H2SO4 in place of `sulphuric acid'. These chemical

`Biological Risks'

abbreviations have been accepted by the FDA and the European Union without the need for translation.

Regulatory Hurdles

The other concern of the FDA relative to labelling is the wording of the regulations and whether it precludes the use of symbols. The FDA has been in on-going consultation with their lawyers to try to reach a conclusion about the constraints/flexibility of the labelling regulations. The section of the Food, Drug and Cosmetic Act and the two regulations that govern labelling are Section 201(k) of the Act, 21 CFR 801.15 "Labelling (for all Medical Devices)", and 21 CFR 809.19 "Labelling for In Vitro Diagnostic Products". Section 201(k) of the Food, Drug and Cosmetic Act states: "The term "label" means a display of written,

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Reference Section

printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper." 21 CFR 801.15 states: "(c)(1) 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.... (c)(2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language. (c)(3) If the labeling contains any representation in a foreign language, 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 foreign language." 21 CFR 809.19 is specific to in vitro diagnostic products and states that: "A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in §809.3(a) of this chapter shall be deemed to be in compliance with the requirements of this section and section 502(f)(1) of the act if it meets the requirements of §809.10 of this chapter." Section 809.10 describes the type of information required to be on the labelling of in vitro diagnostic products but does not specify the means of conveying the information. To date, the FDA Office of Compliance has taken the position that symbols without accompanying English text constitute misbranding based on 21 CFR 801.15. It is the FDA's conclusion that the

general labelling regulation requires all information to be present in English `words' (implying no symbols) and that all English words must be translated into any foreign languages on the labelling. There are several counter-arguments being offered to this interpretation. One is that since symbols are universal, their presentation can be considered to be in English and the other foreign languages as described in 21 CFR 801.15. Another counterargument is that Section 201(k) of the Food, Drug and Cosmetic Act, which describes the laws that govern labelling, does not specify that the information must be in word format. In fact, it appears to give options by using the phrasing "written, printed or graphic matter" and "word, statement or other information". A third counter-argument specific to in vitro diagnostic products is that 21 CFR 801.119 defers the labelling requirements for these products to 21 CFR 809.10, a section of the regulations that also does not specify the format of the information.

Conclusions

In conclusion, the need to address the global labelling information requirements is imperative, and the implementation of symbols seems to be the best first step. Two major concerns with their implementation are: 1. incorrect use of the product misinterpretation of the symbols; and due to

2. misbranding of the product due to the labelling regulations. The first concern is addressed by the use of only those symbols that are more common and intuitive. With regards to the second concern, the European Medical Device and IVD Directives already support their use. In the opinion of the author, the FDA laws and regulations governing at least the in vitro diagnostic products are flexible enough to permit the use of symbols without requiring new laws to be written. s

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