Food and Drug Administration, HHS.
Direct final rule; confirmation of effective date.
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.
Effective date confirmed: October 27, 2008.Start Further Info
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.End Further Info End Preamble Start Supplemental 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.Start Signature
Dated: September 11, 2008.
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21756 Filed 9-16-08; 8:45 am]
BILLING CODE 4160-01-S