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Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability; Correction

---
identifier: "/us/fr/01-15911"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "01-15911"
section_name: "Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability; Correction"
positive_law: false
currency: "2001-06-26"
last_updated: "2001-06-26"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "01-15911"
document_type: "notice"
publication_date: "2001-06-26"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "66 FR 33966"
fr_volume: 66
docket_ids:
  - "Docket No. 01D-0232"
fr_action: "Notice; correction."
---

#  Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability; Correction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 June 1, 2001 (66 FR 29822). The document announced the availability of the draft guidance entitled “Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff.” The document published inadvertently omitting the address for the Dockets Management Branch. This document corrects that error.

**FOR FURTHER INFORMATION CONTACT:**

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

**SUPPLEMENTARY INFORMATION:**

In the *Federal Register* of Friday, June 1, 2001, in FR Doc. 01-13731, on page 29822, in the third column, correct the *ADDRESSES* caption to read:

*ADDRESSES:* Submit written requests for single copies on a 3.5′′ diskette of the draft guidance document entitled “Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff” to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818. Submit written comments concerning this draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the *SUPPLEMENTARY INFORMATION* section for information on electronic access to the draft guidance document.

Dated:  June 19, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.