Medical Devices: Cardiovascular Devices: Reclassification of the Arrhythmia Detector and Alarm; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of October 28, 2003 (68 FR 61342). That document issued a final rule reclassifying arrhythmia detector and alarm devices from class III to class II (special controls). This device is used to monitor an electrocardiogram (ECG) and to produce a visible or audible signal or alarm when an atria or ventricular arrhythmia occurs. The document published with an inadvertent error. This document corrects that error.

EFFECTIVE DATE:

March 8, 2004

FOR FURTHER INFORMATION CONTACT:

Elias Mallis, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-441-8571, ext. 177.

SUPPLEMENTARY INFORMATION:

In FR Doc. 03-27115, appearing on page 61342 in the Federal Register of Tuesday, October 28, 2003, the following correction is made:

On page 61344, in the first column, in § 870.5310 Automated external defibrillator, beginning in the seventh line, the parenthetical “(restoring normal hearth rhythm)” is corrected to read “(restoring normal heart rhythm).”