Food and Drug Administration, HHS.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the availability of a draft guidance document concerning the use of these symbols in labeling of IVDs.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:
|Item No.||Title of Standard||Reference No. and Date|
|30||Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatability—Requirements and Tests||ANSI/AAMI/IEC 60601-1-2:2001|
|31||Symbols to be Used With Medical Device Labels, Labeling and Information to be Supplied||ISO 15223:2000|
|32||Graphical Symbols for Use in the Labeling of Medical Devices||EN 980:1996+A1:1999+A2:2001|
2. On page 22399, in the first table, the entries for item nos. 30, 31, and 32 are removed.Start Signature
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