[Federal Register: January 12, 2007 (Volume 72, Number 8)]
[Rules and Regulations]               
[Page 1460]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja07-14]                         


[[Page 1460]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 807, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 
and 892

[Docket No. 2006N-0335]

 
Medical Devices; Reprocessed Single-Use Devices; Requirement for 
Submission of Validation Data; Withdrawal

ACTION: Direct final rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) published a direct 
final rule that appeared in the Federal Register of September 25, 2006 
(71 FR 55729), that would have amended certain classification 
regulations for reprocessed single-use devices (SUDs) whose exemption 
from premarket notification (510(k)) requirements have been terminated 
and other reprocessed SUDs already subject to premarket notification 
for which validation data, as specified under the Medical Device User 
Fee and Modernization Act of 2002, are necessary in a 510(k). FDA 
stated in the direct final rule that, if it received a significant 
adverse comment by December 11, 2006, FDA would publish a notice of 
withdrawal. FDA received two comments and considers at least one of 
these comments a significant adverse comment and, therefore, is 
withdrawing the direct final rule. Accordingly, the agency will 
consider the comments received under our usual procedures for notice 
and comment in connection with the notice of proposed rulemaking that 
was published in the Federal Register of September 25, 2006 (71 FR 
55748) as a companion to the direct final rule.

DATES: The direct final rule published at 71 FR 55729 on September 25, 
2006, is withdrawn as of January 12, 2007.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Devices and Radiological Health (HFZ-404), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-
4040.

 Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act 
and under authority delegated to the Commissioner of Food and Drugs, 
the direct final rule published on September 25, 2006 (71 FR 55729), is 
withdrawn.

    Dated: January 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-105 Filed 1-9-07; 2:49 pm]

BILLING CODE 4160-01-S
