FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: MEDICAL DEVICES; EXEMPTIONS FROM PREMARKET NOTIFICATION: CLASS II DEVICES; REQUEST FOR COMMENTS

WASHINGTON, Feb. 6 -- Food and Drug Administration has issued a notice called: Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments.

The notice was published in the Federal Register on Feb. 6 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devi...