[Federal Register: June 15, 2005 (Volume 70, Number 114)]
[Rules and Regulations]               
[Page 34652]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

21 CFR Part 803

[Docket No. 2004N-0527]

Medical Devices; Medical Device Reporting; 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 July 13, 2005, for the direct final rule that 
appeared in the Federal Register of February 28, 2005 (70 FR 9516). The 
direct final rule revised the medical device reporting regulations into 
plain language in order to make the regulations easier to understand. 
This document confirms the effective date of the direct final rule.

DATES: Effective date confirmed: July 13, 2005.

FOR FURTHER INFORMATION CONTACT: Howard Press, Center for Devices and 
Radiological Health (HFZ-531), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2983.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 28, 2005 
(70 FR 9516), FDA solicited comments concerning the direct final rule 
for a 75-day period ending May 16, 2005. FDA stated that the effective 
date of the direct final rule would be on July 13, 2005, 60 days after 
the end of the comment period, unless any significant adverse comment 
was submitted to FDA during the comment period. FDA received 16 
comments, 3 of which supported the plain language revisions and several 
of which requested further revisions or substantive changes to the 
medical device reporting rule. The agency did not receive any 
significant adverse comment on the plain language revisions.

    Authority: Therefore, under the Federal Food, Drug, and Cosmetic 
Act, and under authority delegated to the Commissioner of Food and 
Drugs, notice is given that no objections were filed in response to 
the February 28, 2005, direct final rule. Accordingly, the 
amendments issued thereby are effective July 13, 2005.

    Dated: June 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11786 Filed 6-14-05; 8:45 am]