Medical Device Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 8, 2004 (69 FR 18472). That document corrected a final rule that appeared in the Federal Register of March 10, 2004 (69 FR 11310). The April 8, 2004, document published with inadvertent errors. This document corrects those errors.

DATES:

This rule is effective May 7, 2004.

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. 04-8022, appearing on page 18472 in the Federal Register of Thursday, April 8, 2004, the following corrections are made:

1. On page 18472, in the third column, under the FOR FURTHER INFORMATION CONTACT heading, the address is corrected to read “Joyce A. Strong, Office of Policy and Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.”

2. On page 18473, in the first column, in § 807.22, in paragraph (a), the first sentence is corrected to read “The first registration of a device establishment shall be on Form FDA-2891 (Initial Registration of Device Establishment).”