[Federal Register: November 30, 2004 (Volume 69, Number 229)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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
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
Research (HFM-390), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301-827-3524.
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
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
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
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
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.
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