03-18689. 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

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.

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.

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]”.

Dated: July 17, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.