Guidance for Industry and FDA 

Staff 

Use of Symbols on Labels and in 

Labeling of In Vitro Diagnostic 

Devices Intended for Professional 

Use 

Document issued on: November 30, 2004

The draft of this document was issued on October 28, 2003.

The information collection provisions in this guidance have been approved under OMB 

control number 0910-0553. This approval expires 10/31/2007. An agency may not 

conduct or sponsor, and a person is not required to respond to, a collection of information 

unless it displays a currently valid OMB number. 

For questions regarding this document contact Paula Silberberg, Office of Communication, 

Education and Radiation Programs, Center for Devices and Radiological Health, 240-276-

3234; Terri Garvin, Office of In Vitro Diagnostic Devices Evaluation and Safety, Center 

for Devices and Radiological Health, 240-276-1326; or Sheryl Kochman, Office of 

Blood Research and Review, Center for Biologics Evaluation and Research, 301-827-6123. 

U.S. Department of Health and Human Services 

Food and Drug Administration 

 Center for Devices and Radiological Health 

Center for Biologics Evaluation and Research 
Contains Nonbinding Recommendations 

Preface

Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration 

to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers 

Lane, Room 1061, (HFA-305), Rockville, MD, 20852. 

Alternatively, electronic comments may be submitted to 

http://www.fda.gov/dockets/ecomments. When submitting comments, please refer to

Docket No. 2003D-0383. Comments may not be acted upon by the Agency until the 

document is next revised or updated. 

Additional Copies 

Additional copies are available from the Internet at: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/

 GuidanceDocuments/UCM085404.htm or 

or http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/

GuidanceDocuments/UCM085679.pdf

You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic 

copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. 

Please use the document number (4444) to identify the guidance you are requesting. 

Or, you may contact: 

Office of Communication, Training, and 

Manufacturers Assistance, HFM-40 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

1401 Rockville Pike, Rockville, MD 20852-1448 

Phone: 800-835-4709 or 301-827-1800 
Contains Nonbinding Recommendations 

Table of Contents 

Introduction......................................................................................................................... 1 

Background......................................................................................................................... 2 

Legal Considerations .......................................................................................................... 3

FDA Recognizes Selected ISO 15223 and EN 980 Medical Device Symbols................... 5 

For In Vitro Diagnostic Devices......................................................................................... 7 

For Professional Labels and Labeling................................................................................. 7 

Glossary of Terms............................................................................................................... 7

Educational Outreach.......................................................................................................... 8

Application of Guidance to Other Symbols........................................................................ 8 

Implementation ................................................................................................................... 9 
Contains Nonbinding Recommendations 

Guidance for Industry and FDA Staff 

Use of Symbols on Labels and in Labeling 

of In Vitro Diagnostic Devices Intended 

for Professional Use 

This guidance represents the Food and Drug Administration's (FDA's) current 

thinking on this topic. It does not create or confer any rights for or on any person and 

does not operate to bind FDA or the public. You can use an alternative approach if the 

approach satisfies the requirements of the applicable statutes and regulations. If you

want to discuss an alternative approach, contact the FDA staff responsible for 

implementing this guidance. If you cannot identify the appropriate FDA staff, call the 

appropriate number listed on the title page of this guidance. 

I. Introduction

This document provides guidance on the use of selected symbols in place of text to 

convey some of the information required for in vitro diagnostic devices (IVDs) 

intended for professional use by 21 CFR 809.10, FDA’s labeling requirements for in 

vitro diagnostic devices, and 21 CFR parts 610 and 660, FDA’s labeling requirements 

for biologics (including IVDs) that are licensed under the Public Health Service 

(PHS) Act. These recommendations apply to the use of symbols on the labels and in 

labeling only of IVDs intended for professional use, and not for over-the-counter or 

prescription home-use IVDs. This guidance does not address the use of “unique and 

generally recognized” symbols to identify the manufacturer of a device, as described 

in Section 502(u) of the Food, Drug and Cosmetic Act. 

Note: The term “symbols” used throughout this guidance refers to the use of 

graphical symbols without equivalent accompanying text. 

This guidance is intended for both industry and FDA. 

FDA's guidance documents, including this guidance, do not establish legally enforceable 

responsibilities. Instead, guidances describe the Agency's current thinking on a topic and 

should be viewed only as recommendations, unless specific regulatory or statutory 

requirements are cited. The use of the word should in Agency guidances means that 

something is suggested or recommended, but not required. 

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Contains Nonbinding Recommendations 

The Least Burdensome Approach 

The issues identified in this guidance document represent those that we believe should be 

addressed before your device can be marketed. In developing the guidance, we carefully 

considered the relevant statutory criteria for Agency decision-making. We also considered 

the burden that may be incurred in your attempt to follow the guidance and address the 

issues we have identified. We believe that we have considered the least burdensome

approach to resolving the issues presented in the guidance document. If, however, you 

believe that there is a less burdensome way to address the issues, you should follow the 

procedures outlined in the “A Suggested Approach to Resolving Least Burdensome

Issues” document. It is available on our Center web page at 

http://www.fda.gov/cdrh/modact/leastburdensome.html. 

II. Background 

The market for in vitro diagnostic devices is international. European Union (EU) 

member countries have attempted to harmonize their national legislation governing IVDs 

through the European Union’s Directive on In Vitro Diagnostic Medical Devices, 

(Directive 98/79/EC) (“IVD Directive”). The EU’s IVD Directive went into full effect 

on December 8, 2003. As of that date, IVD products marketed in the EU must comply

with the IVD Directive and bear the CE mark (mark showing that the product is certified 

for sale in the European community) to indicate compliance. 

The EU’s IVD Directive and FDA regulations in 21 CFR 809.10, 21 CFR part 610, and 

21 CFR part 660 all require substantial information to appear on the IVD itself and/or in 

its labeling. The IVD Directive specifically allows each EU member state to require that 

such information appear in its national language, so that a single IVD could be required 

to bear labeling in multiple languages in order to be sold in the EU. As an alternative, the 

IVD Directive encourages that, in place of text, IVDs use symbols from harmonized 

standards to convey the required information. Given that the use of national languages 

may be required by individual member states and that most IVDs and their packaging are 

quite small, the IVD Directive’s symbols provision represents an avenue through which 

manufacturers can achieve compliance in an international marketplace. 

Similarly, the use of symbols helps IVD manufacturers to create uniform labels and 

labeling for the United States and European Union (and any other countries that may 

permit use of symbols from these international standards), instead of needing designated 

labels for each marketplace. Because symbols take up less space than the text for which 

they may substitute, the use of symbols promotes less crowded and more legible IVD 

labels. An additional advantage is that there are likely to be fewer labeling errors when 

using a single label, rather than having one set of labels for use in the United States and 

another set for use in the European Union. Of course, it is essential that the symbol 

convey the substance of the deleted text and be widely understood. 

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III. Legal Considerations 

FDA regulations in 21 CFR 809.10 and 21 CFR parts 610 and 660 define information 

required to appear on the label and in labeling for IVDs marketed in the United States. 

These regulations specify the content of labels and labeling and the order in which this 

information should be presented. With a few exceptions, these regulations do not specify 

wording that manufacturers must use to meet these requirements. 

Under Section 502(c) of the Food, Drug, and Cosmetic Act (the Act), a drug or device is 

misbranded “If any word, statement, or other information required by or under authority 

of this Act to appear on the label or labeling is not prominently placed thereon with such 

conspicuousness (as compared with other words, statements, designs, or devices, in the 

labeling) and in such terms as to render it likely to be read and understood by the 

ordinary individual under customary conditions of purchase and use." The information 

required by 21 CFR 809.10 and 21 CFR parts 610 and 660 thus must also meet the 

requirements of Section 502(c) of the Act. 

For a symbol to be used to convey information required by the regulations, it must be a 

“term” that is “. . . likely to be read and understood by the ordinary individual under 

customary conditions of purchase and use.” This guidance addresses specific symbols 

from two harmonized international standards that FDA believes can satisfy this 

requirement. Thus, in accordance with section 514(c) of the Act, FDA recognizes these 

specific symbols for use on the label and in the labeling of certain IVDs. (See Federal 

Register of April 28, 2003 (68 FR 22391); corrected with respect to the extent of 

recognition by October 28, 2003 (68 FR 61448). In this context, we narrowly define the 

“ordinary user” as the professional user of IVDs. The “customary conditions of purchase 

and use” are within the laboratory environment. Through the process for recognizing 

international consensus standards, under section 514(c) of the Act, FDA received 

acceptable evidence in the form of a user comprehension study conducted in the United 

States that indicates that this target audience can understand labels and labeling that use 

the 25 symbols identified here in place of equivalent text. 

Use of these symbols can also help to satisfy the “conspicuousness” requirement of 

section 502(c). As explained above, most IVD devices are small and have limited label 

space. By using symbols in place of some textual statements, manufacturers may 

enhance the legibility of labeling and thus improve the “conspicuousness” of required 

information. In the study submitted to FDA in support of recognition of these standard 

symbols, participants overwhelmingly favored the use of the tested symbols in place of 

the text equivalents. 

This guidance document recognizes that the symbols for which comprehension data have 

been presented to, and accepted by, the FDA through the consensus standards recognition 

process may be used as terms to communicate to professional users of IVDs information 

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Contains Nonbinding Recommendations 

required under 21 CFR 809.10 and 21 CFR parts 610 and 660.1 Manufacturers remain 

responsible for adhering to the substantive requirements of these provisions, and to all 

other labeling requirements under the Act and regulations. 

As stated above, some provisions of 21 CFR 809.10 and 21 CFR part 660 do specify 

particular labeling language. As a matter of enforcement discretion, FDA does not intend 

to object to the use of: 

• the symbol consisting of the letters “IVD” in a box in place of the statement “For 

In Vitro Diagnostic Use” required by 21 CFR 809.10(a)(4), 809.10(b)(5)(ii), 

660.28(b)(13), and 660.55(b)(10) 

• the symbol that represents “For IVD Performance Evaluation only” in place of the 

statement, “For Investigational Use Only. The performance characteristics of this 

product have not been established.” Because FDA equates this symbol with this 

statement, required by 21 CFR 809.10(c)(2)(ii), use of this symbol should be 

limited to those IVDs that are subject to that requirement. IVDs that may be 

subject to other labeling requirements regarding their investigational or research 

status, such as the requirements of 21 CFR 812.5(a), 809.10(c)(2)(i), or 312.6(a), 

must continue to bear the textual statements required by those provisions and 

should not bear this symbol. 

The symbol that represents “Authorized representative in the European Community” is 

not needed to fulfill the labeling requirements of 21 CFR 809.10 or 21 CFR parts 610 or 

660, as U.S. regulations do not require this information to be provided. IVD 

manufacturers who wish to use this symbol on the label or labeling to be used in both the 

U.S. and European Union in order to fulfill European labeling requirements may do so as 

long as the use of this symbol does not violate other U.S. labeling requirements. For 

example, if the “Authorized representative in the European Community” symbol is used 

in a manner that interferes with the communication of information required by U.S. law, 

the device could be misbranded under section 502(c) of the Act. 

 1 21 CFR 801.15(c) says that a device is misbranded under section 502(c) of the Act 

unless: 

“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: Provided, 

however, That in the case of articles distributed solely in the Commonwealth of Puerto 

Rico or in a Territory where the predominant language is one other than English, the 

predominant language may be substituted for English.” Because, as explained above, 

FDA concludes that the symbols from international consensus standards recognized in 

this guidance document can be understood by relevant users in the United States and thus 

satisfy the underlying requirements of section 502(c), the Agency does not intend to 

interpret their use to violate 21 CFR 801.15(c). This interpretation is consistent with 

international harmonization. 

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Contains Nonbinding Recommendations 

IV. FDA Recognizes Selected ISO 15223 and EN 980 

Medical Device Symbols 

In accordance with the consensus standards recognition process, established by section 

514(c) of the Act, in the Federal Register of April 28, 2003 (68 FR 22391), FDA 

published a notice recognizing certain standards for use in premarket reviews including 

the two standards listed below concerning the use of symbols in labeling. In the Federal 

Register of October 28, 2003 (68 FR 61448), FDA published a notice correcting the 

April 28th notice with respect to the extent of the recognition of the two standards. FDA 

recognizes 25 symbols for IVD devices for professional use from the following two 

international consensus standards: 

• ISO 15223, Medical Devices – Symbols to be used with medical device labels, 

labeling and information to be supplied 

• EN 980, Graphical symbols for use in the labeling of medical devices 

The following chart displays the symbols with their definitions. 

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Validation data introduced in FDA’s consensus standards recognition process satisfies 

FDA that professional users of IVDs, the intended audience for this labeling, will 

understand the 25 symbols identified above. Specifically, industry-sponsored studies 

conducted in the United States with professional laboratory test users from a variety of 

educational backgrounds demonstrated end-user comprehension of the symbols in 

context, with an accompanying glossary and other educational outreach. Sections V and 

VI of this guidance explain the limitations of this recognition, which flow from the 

validation data. 

V. For In Vitro Diagnostic Devices 

FDA recognizes use of these symbols only for the labels and labeling of in vitro 

diagnostic devices. Recognition supports FDA’s efforts to harmonize its regulatory work 

with international standards-making bodies. Recognition is supported by the scope and 

results of the studies performed and submitted to FDA. FDA has not received reports of

studies supporting use of any additional symbols on IVDs, nor supporting recognition of 

any symbols for use on other devices, for which ordinary users and conditions of 

purchase and use would differ from IVDs. 

VI. For Professional Labels and Labeling 

FDA recognizes these symbols only for use on the professional label and in the 

professional labeling of in vitro diagnostic devices. FDA does not recognize the symbols 

for use in the labels and labeling of over-the-counter or prescription home-use IVDs. 

Validation data introduced through FDA’s consensus standards recognition process 

supported the use of symbols for IVD professional labels and labeling, not for consumer

labeling. 

VII. Glossary of Terms 

FDA recommends that a glossary of terms accompany each IVD to define all of the 

symbols used on that device’s labels and/or labeling. This glossary may also contain 

other symbols identified by FDA in its recognition of ISO 15223 and EN 980, whether or 

not used in labeling for the particular device. The glossary allows users to become

familiar with the meaning of the symbols and also acts as a reference for users to look up 

any definitions they may not recall. In these respects, the glossary helps to satisfy the 

requirements of Section 502(c) of the Act by ensuring that IVD users, under customary 

conditions of use, have access to necessary reference materials, making it more likely that 

they can understand the symbols. Since users can keep the package insert readily 

accessible, FDA encourages the inclusion of the glossary in the package insert. The 

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Contains Nonbinding Recommendations 

glossary accompanying the IVD may be a separate labeling piece in the form of a 

separate sheet of paper or card while IVD labeling is being updated and revised, but FDA 

recommends that to ensure ease of access, the glossary of symbols ultimately appear as 

part of the package insert accompanying the IVD. 

VIII. Educational Outreach 

FDA recommends that manufacturers conduct an educational outreach effort for the 

intended audience to enhance the understanding of newly introduced symbols. The 

educational outreach should target the various professional users of IVDs (e.g., laboratory 

technologists, nurses, laboratory assistants, medical assistants). FDA recommends the 

following possible methods for education: 

• print materials such as glossaries, wall charts, articles in the laboratory 

press 

• information on industry web sites 

• dear health care provider letters 

• advertisements in professional journals 

• training sessions 

The educational outreach should extend to all of those involved in the IVD distribution 

chain, such as wholesalers and distributors, who need to be aware of symbols relating to 

expiration date and storage requirements. 

Such educational programs also help satisfy the requirements of Section 502(c) of the Act 

by creating an environment in which IVD users are likely to understand the symbols 

used. 

FDA recommends that the manufacturers evaluate the educational outreach activities to 

determine if these activities are effective in educating IVD users to comprehend the 

meaning of the symbols. 

IX. Application of Guidance to Other Symbols 

CDRH will consider recognizing other symbols for use on the labels and in the labeling 

of IVDs through FDA’s consensus standards recognition process. For additional 

information about this process, refer to the web page for FDA’s Standards Program: 

http://www.fda.gov/cdrh/stdsprog.html. 

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X. Implementation 

For IVDs intended for professional use for which FDA has approved an application for 

Premarket Approval (PMA), manufacturers may change the labeling to include FDA 

recognized symbols in place of equivalent text without approval of PMA supplements. 

Other changes to labeling may require new PMA submissions, in accordance with 21 

CFR 814.39(b). PMA holders that implement this type of change should notify the 

Agency of the change in the next annual report to the PMA, in accordance with 21 CFR 

814.84. Similarly, biologics license holders that implement this type of change should 

notify the Agency of the change, which the Agency will consider an editorial or similar 

minor change, in the next annual report to the Manufacturers Biologics License 

Application (BLA), in accordance with 21 CFR 601.12(f)(3)(A). Manufacturers may 

substitute recognized symbols in place of equivalent text on existing labels and labeling 

for IVDs intended for professional use that received Premarket Notification [510(k)] 

clearance without submitting a new 510(k). (For information on other labeling changes 

that may require submission of a new 510(k), please see 21 CFR 807.81(a)(3), and 

FDA’s guidance document, “Deciding When to Submit a 510(k) for a Change to an 

Existing Device,” available at http://www.fda.gov/cdrh/ode/510kmod.pdf.) 

Manufacturers and importers should report to FDA any adverse events that arise from the 

use of symbols in labeling of IVDs intended for professional use, as required by 21 CFR 

part 803. Reporting forms and instructions are available at 

http://www.fda.gov/medwatch/safety.htm.