[Federal Register: October 28, 2003 (Volume 68, Number 208)]
[Page 61448]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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draft guidance document concerning the use of these symbols in labeling 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:

   Item No.       Title of Standard          Reference No. and Date
30             Medical Electrical       ANSI/AAMI/IEC 60601-1-2:2001
                Equipment--Part 1-2:
                General Requirements
                for Safety--Collateral
                ments and Tests
31             Symbols to be Used With  ISO 15223:2000
                Medical Device Labels,
                Labeling and
                Information to be
32             Graphical Symbols for    EN 980:1996+A1:1999+A2:2001
                Use in the Labeling of
                Medical Devices

    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]