E8-21756. Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Direct final rule; confirmation of effective date.

SUMMARY:

The Food and Drug Administration (FDA) is confirming the effective date of October 27, 2008, for the final rule that appeared in the Federal Register of June 13, 2008 (73 FR 33692). The direct final rule amends the Medical Device Reporting regulation by removing the requirement for baseline reports. This document confirms the effective date of the direct final rule.

DATES:

Effective date confirmed: October 27, 2008.

FOR FURTHER INFORMATION CONTACT:

Howard A. Press, Center for Devices and Radiological Health (HFZ-531), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3457.

SUPPLEMENTARY INFORMATION:

In the Federal Register of June 13, 2008 (73 FR 33692), FDA solicited comments concerning the direct final rule for a 75-day period ending August 27, 2008. FDA stated that the effective date of the direct final rule would be on October 27, 2008, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments.

Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, the amendments issued thereby become effective on October 27, 2008.

Dated: September 11, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.