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 June 23, 2000 (65 FR 39098). The document classified devices to relieve acute upper airway obstruction. These type devices were classified into class II. The preamble to the final rule correctly states that the devices were exempt from premarket notification, but this exemption was not reflected in the regulatory text. This document corrects that error.
DATES:
This rule is effective August 3, 2000.
FOR FURTHER INFORMATION CONTACT:
Carroll O'Neill, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8262, ext. 170.
SUPPLEMENTARY INFORMATION:
In FR Doc. 00-15864, appearing on page 39098 in the Federal Register of June 23, 2000, the following correction is made:
On page 39099, in the third column, in § 868.5115 Device to relieve acute upper airway obstruction, in paragraph (b), insert at the end of the paragraph the sentence “The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to § 868.9.”
Dated: July 17, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and Radiological Health.
[FR Doc. 00-19593 Filed 8-2-00; 8:45 am]
BILLING CODE 4160-01-F