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

---
identifier: "/us/fr/03-18689"
source: "fr"
legal_status: "authoritative_unofficial"
title: "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"
title_number: 0
title_name: "Federal Register"
section_number: "03-18689"
section_name: "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"
positive_law: false
currency: "2003-07-23"
last_updated: "2003-07-23"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "03-18689"
document_type: "notice"
publication_date: "2003-07-23"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "68 FR 43538"
fr_volume: 68
docket_ids:
  - "Docket No. 2003D-0282"
fr_action: "Notice; correction."
---


#  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.