Zdrowie i gospodarka · 12/01/2007

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