[Federal Register: November 30, 2004 (Volume 69, Number 229)]
[Notices]               
[Page 69606-69608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no04-60]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0383]

 
Guidance for Industry and Food and Drug Administration 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 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 
from international standards already recognized by FDA 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.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the 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 one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
301-443-8818. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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

[[Page 69607]]

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 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 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 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 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 (21 U.S.C. 360d(c)), in the Federal Register of April 28, 
2003 (68 FR 22391), corrected by 68 FR 61448 (October 28, 2003), FDA 
recognized for use on the labels and labeling of IVDs intended for 
professional use 25 symbols from the 2 international consensus 
standards:
     ISO 15223, Medical Devices; Symbols to be Used With 
Medical Device Labels, Labeling and Information to be Supplied, and
     EN 980, Graphical Symbols for Use in the Labeling of 
Medical Devices.
    The guidance document entitled ``Use of Symbols on Labels and in 
Labeling of In Vitro Diagnostic Devices Intended for Professional Use'' 
provides guidance on the use of those recognized symbols.
    FDA announced the availability of the level 1 draft guidance 
document in the Federal Register of October 28, 2003 (68 FR 61449). 
While comments on guidances may be submitted at any time, FDA invited 
interested persons to submit written or electronic comments on the 
draft guidance by November 28, 2003, to ensure adequate consideration 
of the comments. The comment period for the proposed information 
collection provisions closed on December 29, 2003. FDA received seven 
comments from manufacturers on the draft guidance. However, many of the 
comments addressed issues beyond the scope of the use of the 25 FDA 
recognized symbols on IVD for professional use. FDA will continue to 
study these comments to determine what other actions may be 
appropriate. One comment suggested that the glossary of symbols 
recommended by the guidance be permitted to be provided as a separate 
labeling piece, rather than being incorporated into the package insert. 
In the guidance document, FDA continues to express its preference for 
the inclusion of the glossary as part of the package insert, although 
it recognizes that while package inserts are being revised, 
manufacturers may prefer to provide the glossary as a separate labeling 
piece. As with all aspects of the guidance, this position represents 
FDA's recommendation, and manufacturers may select an alternative 
approach if that approach satisfies the requirements of the applicable 
statute and regulations.
    In addition, in the guidance document, FDA has decided to remove 
the statement in section III where FDA had proposed to exercise 
enforcement discretion if a company used the symbol that represents 
``Manufacturer'' to satisfy Sec.  610.64. Upon reflection, that symbol 
does not appear applicable to Sec.  610.64.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance, when finalized, 
will represent 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, 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 (). Follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A search capability for all CDRH guidance 

documents is available on the Division of Dockets Management Internet 
site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.


IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the PRA). 
The collections of information described in sections VII and VIII of 
the guidance regarding a glossary of terms and educational outreach 
were approved by OMB in accordance with the PRA under OMB control 
number 0910-0553 which

[[Page 69608]]

expires on October 31, 2007. The 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 the 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. 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) were 
approved under OMB control number 0910-0527. The collections of 
information described in section X of the guidance, regarding annual 
reports, were approved under OMB control numbers 0910-0231 and 0910-
0338. 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 a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: November 9, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-26333 Filed 11-29-04; 8:45 am]

BILLING CODE 4160-01-S