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Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices; Availability; Correction

Document Details

Information about this document as published in the Federal Register.

Published Document

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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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 July 8, 2003 (68 FR 40679). The document announced the availability of a guidance entitled “Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices; Availability.” The document published with the incorrect docket number. This document corrects that error.

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FOR FURTHER INFORMATION CONTACT:

Joyce A. Strong, Office of Policy and Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.

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SUPPLEMENTARY INFORMATION:

In FR Doc. 03-17135, appearing on page 40679 in the Federal Register of July 8, 2003, the following correction is made:

1. On page 40679, in the first column, in the heading of the document, “[Docket No. 2003D-0232]” is corrected to read “[Docket No. 2003D-0282]”.

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Dated: July 17, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-18689 Filed 7-22-03; 8:45 am]

BILLING CODE 4160-01-S