[Federal Register Volume 68, Number 208 (Tuesday, October 28, 2003)]
[Notices]
[Page 61448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27118]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0077]
FDA Modernization Act of 1997: Modifications to the List of
Recognized Standards, Recognition List Number: 008; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of April 28, 2003 (68 FR 22391).
The document announced a publication entitled ``FDA Modernization Act
of 1997; Modifications to the List of Recognized Standards, Recognition
List Number: 008.'' The publication contains modifications the agency
is making to the list of standards FDA recognizes for use in the
premarket reviews. The document was published with inadvertent errors.
This document corrects those errors and provides clarification.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4766, ext. 156.
SUPPLEMENTARY INFORMATION: FDA also intended to note that it is
limiting its recognition of standards 31 and 32 to the use of 25
symbols for labeling of in vitro diagnostic (IVD) devices used by
professional IVD users. Elsewhere in this issue of the Federal
Register, FDA is publishing a notice announcing the availability of a
draft guidance document concerning the use of these symbols in labeling
of IVDs.
In FR Doc. 03-10417, appearing on page 22391 in the Federal
Register of Monday, April 28, 2003, the following corrections are made:
1. On page 22398, under ``B. General'', correct the table to read:
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Item No. Title of Standard Reference No. and Date
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30 Medical Electrical ANSI/AAMI/IEC 60601-1-2:2001
Equipment--Part 1-2:
General Requirements
for Safety--Collateral
Standard:
Electromagnetic
Compatability--Require
ments and Tests
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31 Symbols to be Used With ISO 15223:2000
Medical Device Labels,
Labeling and
Information to be
Supplied
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32 Graphical Symbols for EN 980:1996+A1:1999+A2:2001
Use in the Labeling of
Medical Devices
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2. On page 22399, in the first table, the entries for item nos. 30,
31, and 32 are removed.
Dated: October 2, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27118 Filed 10-27-03; 8:45 am]
BILLING CODE 4160-01-S