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

WASHINGTON, May 1 -- Food and Drug Administration has issued a notice called: Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments.

The notice was published in the Federal Register on May 1 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is announcing its intent to exempt from premarket notification requirements certain class II clinical toxicology test system devices. 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 devices included in thi...