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FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 008; Correction

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.


Notice; correction.


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.

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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.

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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 Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the availability of a draft guidance document concerning the use of these symbols in labeling of IVDs.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 StandardReference No. and Date
30Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatability—Requirements and TestsANSI/AAMI/IEC 60601-1-2:2001
31Symbols to be Used With Medical Device Labels, Labeling and Information to be SuppliedISO 15223:2000
32Graphical Symbols for Use in the Labeling of Medical DevicesEN 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.

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Dated: October 2, 2003.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. 03-27118 Filed 10-27-03; 8:45 am]