Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Withdrawal
Direct Final Rule; Withdrawal.
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.
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The direct final rule published at 71 FR 55729 on September 25, 2006, is withdrawn as of January 12, 2007.
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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to the Commissioner of Food and Drugs, the direct final rule published on September 25, 2006 (71 FR 55729), is withdrawn.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.
Assistant Commissioner for Policy.
[FR Doc. 07-105 Filed 1-9-07; 2:49 pm]
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