Regulatory News In Brief

Reprocessing rule: FDA Jan. 12 rescinds a Sept. 25, 2006, final rule that amended the validation data requirements for 52 types of reprocessed single-use devices, including catheter guide wires, oximeters and keratomes. The withdrawal is due to a "significant adverse comment" on the rule received from eye-care firm Alcon. FDA will reconsider the topic and propose a new regulation in the future...