[Federal Register Volume 68, Number 208 (Tuesday, October 28, 2003)]
[Notices]
[Pages 61449-61451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27117]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0383]


Draft Guidance for Industry and FDA Staff; Use of Symbols on 
Labels and in Labeling of In Vitro Diagnostic Devices Intended for 
Professional Use; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Use of Symbols on Labels 
and in Labeling of In Vitro Diagnostic Devices Intended for 
Professional Use.'' 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 FDA's labeling requirements for IVDs. This draft 
guidance is not final nor is it in effect at this time.

DATES: Submit written or electronic comments on this draft guidance by 
November 28, 2003, to ensure adequate consideration of the comments in 
the preparation of a final guidance. However, you may submit comments 
at any time. Submit written or electronic comments on the proposed 
information collection provisions by December 29, 2003.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Use of Symbols on 
Labels and in Labeling of In Vitro Diagnostic Devices Intended for 
Professional Use'' to the Division of Small Manufacturers, 
International, and Consumer Assistance (HFZ-220), Center for Devices 
and Radiological Health, Food and Drug Administration, 1350 Piccard 
Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to 
assist that office in processing your request, or fax your request to 
301-443-8818. You may also submit written requests for single copies of 
the draft guidance to the Office of Communication, Training, and 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. Send one self-addressed adhesive label to 
assist the office in processing your requests. The draft guidance may 
also be obtained by mail by calling the CBER Voice Information System 
at 1-800-835-4709

[[Page 61450]]

or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning the draft guidance and the 
proposed information collections provisions to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft 
guidance and the proposed information collection provisions to http://www.fda.gov/dockets/ecomments. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Paula G. Silberberg, Center for 
Devices and Radiological Health (HFZ-230), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-1217; or 
Sheryl A. Kochman, Center for Biologics Evaluation and Research (HFM-
390), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-3524.

SUPPLEMENTARY INFORMATION:

I. 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 EU's IVD Directive. The 
EU's IVD Directive is in full effect as of 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 Sec.  809.10 (21 CFR 
809.10) and parts 610 and 660 (21 CFR parts 610 and 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 the use of symbols from harmonized standards to convey the 
required information in place of text. 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 the EU (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 EU. Of course, it is essential that the symbol convey the substance 
of the deleted text and be widely understood.
    Therefore, in accordance with the consensus standards recognition 
process, established by section 514(c) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360d(c)), elsewhere in this issue of 
the Federal Register, FDA recognizes 25 symbols from the two 
international consensus standards:
    [sbull] ISO 15223, Medical Devices--Symbols to be Used With Medical 
Device Labels, Labeling and Information to be Supplied, and
    [sbull] EN 980, Graphical Symbols for Use in the Labeling of 
Medical Devices.
    This document provides guidance on the use of those recognized 
symbols.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the agency's current thinking on 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. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statute and 
regulations.

III. Electronic Access

    To receive ``Use of Symbols on Labels and in Labeling of In Vitro 
Diagnostic Devices Intended for Professional Use'' by fax machine, call 
the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone. Press 1 to enter the system. At the second voice 
prompt, press 1 to order a document. Enter the document number (4444) 
followed by the pound sign ([numsign]). Follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. CDRH maintains an entry on the 
Internet for easy access to information including text, graphics, and 
files that may be downloaded to a personal computer with Internet 
access. Updated on a regular basis, the CDRH home page includes device 
safety alerts, Federal Register reprints, information on premarket 
submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturer's assistance, information 
on video conferencing and electronic submissions, Mammography Matters, 
and other device-oriented information. The CDRH Web site may be 
accessed at http://www.fda.gov/cdrh. A search capability for all CDRH 
guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available from CBER at 
http://www.fda.gov/cber/guidelines.htm or on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Sections VII and VIII of the 
guidance propose new recommended collections of information. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information before submitting the 
collection to OMB for approval. To comply with this requirement, FDA is 
publishing notice of the proposed collection of information set forth 
below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques,

[[Page 61451]]

when appropriate, and other forms of information technology.
    Title: Recommended Glossary and Educational Outreach to Support Use 
of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices 
Intended for Professional Use
    Description: This document provides guidance on the voluntary use 
of selected symbols in place of text to convey some of the information 
required for IVDs intended for professional use under Sec.  809.10 
(FDA's labeling requirements for in vitro diagnostic devices) and parts 
610 and 660 (FDA's labeling requirements for biologics (including 
IVDs)) that are licensed under the Public Health Service (PHS) Act. Use 
of these symbols will not result in a new collection of information but 
is a means of fulfilling underlying labeling requirements that are 
subject to OMB clearance. Under section 502(c) of the act (21 U.S.C. 
352), 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.'' This guidance document recommends 
that a glossary of terms accompany each IVD to define the symbols used 
on that device's labels and/or labeling. Furthermore, this guidance 
recommends an educational outreach effort to enhance the understanding 
of newly introduced symbols. Both the glossary and the educational 
outreach help to ensure that IVD users will have enough general 
familiarity with the symbols, as well as quick reference materials 
available, to be likely to understand the symbols used in IVD labeling, 
further ensuring that such labeling satisfies the requirements of 
section 502(c) of the act.
    Respondents: The likely respondents are IVD manufacturers who plan 
to use the selected symbols in place of text on the labels and/or 
labeling of their IVDs.
    FDA estimates the burden of the collection of information in table 
1:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                         Annual Frequency per
            Activity              No. of  Respondents          Response         Total Annual Responses      Hours per Response          Total Hours
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Glossary.......................                 1,742                      1                     1,742                         4               6,968\2\
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Educational outreach...........                 1,742                      1                     1,742                        16                 27,872
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Total..........................  .....................  .....................  ........................  ........................                34,840
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\One-time burden.

    The glossary and educational outreach activities would be carried 
out by domestic and foreign IVD manufacturers. The CDRH Information 
Retrieval System's Registration and Listing Information database 
provided the number of IVD manufacturers as 1,742; 1,206 are domestic 
IVD manufacturers and 536 are foreign manufacturers. Consequently, FDA 
has based its burden estimate on the maximum possible number of 
manufacturers choosing to implement the use of symbols in labeling. The 
number of hours per response for the glossary and educational outreach 
activities were derived from consultation with a trade association and 
FDA personnel. The 4-hour estimate for a glossary is based on the 
average time necessary for a manufacturer to modify the glossary, as 
shown in the draft guidance, for the specific symbols used in labels or 
labeling for the IVDs they manufacture. The 16-hour estimate for 
educational outreach includes activities manufacturers will use to 
educate the various professional users of IVDs about the meaning of the 
IVD symbols. This estimate is based on FDA 's expectation that IVD 
manufacturers will jointly sponsor many educational outreach 
activities.
    This draft guidance document also refers to labeling requirements, 
annual reporting requirements, and other information collections 
established under existing regulations. The collections of information 
described in section III of this guidance that result from Sec.  809.10 
were approved under OMB control number 0910-0485. The collections of 
information described in section III of the guidance that result from 
Sec. Sec.  610.60, 610.61, and 610.62 were approved under OMB control 
number 0910-0338. In accordance with section 3506(c)(2)(A) of the PRA, 
a 60-day notice soliciting public comment on the collections of 
information described in section III of the guidance that result from 
part 660 (Sec. Sec.  660.2, 660.28, 660.35, 660.45, and 660.55) 
published in the Federal Register on July 22, 2003 (68 FR 43359). The 
collections of information described in section X of the guidance, 
regarding annual reports, were approved under OMB control numbers 0910-
0231 and 0910-0315. The collections of information described in section 
X of this guidance, regarding adverse event reporting, were approved 
under OMB control numbers 0910-0437 and 0910-0291.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit comments on the collection of information. Submit a 
single copy of electronic comments to http://www.fda.gov/dockets/ecomments. Submit two hard copies of any mailed comments, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Comments received may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 2, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27117 Filed 10-27-03; 8:45 am]
BILLING CODE 4160-01-S