Document ID: FDA-2008-N-0310-0004
Agency: fda
Document Type: Rule
Title: Medical Devices; Medical Device Reporting; Baseline Reports; Confirmationof Effective Date
Posted Date: 2008-09-17T04:00Z

[Federal Register: September 17, 2008 (Volume 73, Number 181)]
[Rules and Regulations]               
[Page 53686]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se08-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

[Docket No. FDA-2008-N-0310]

 
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.

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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.
[FR Doc. E8-21756 Filed 9-16-08; 8:45 am]

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