FDA WITHDRAWS FINAL RULE ON SUD CLASSIFICATION, CITING ADVERSE EVENT COMMENTS
The FDA is withdrawing a direct final rule that would have amended the classification regulations for reprocessed single-use devices (SUDs) due to adverse event comments it received following the rule's publication Sept. 25, 2006. The withdrawal is effective Jan. 12.
The amended classification regulations would have applied to SUDs "whose exemption from premarket notification, or 510(k), requirements have been terminated and other reprocessed SUDs already subject to premarket notification" for which validataion data are necessary in a 510(k), the FDA said.
The FDA has stated in the final direct rule that, if it received a significant adverse comment by Dec. 11, 2006, it would publish a notice of withdrawal. The agency "received two comments and considers at least one of these comments a significant adverse event comment," it said.