FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; EXEMPTIONS FROM PREMARKET NOTIFICATION: CLASS II DEVICES; CLINICAL ELECTRONIC THERMOMETERS

WASHINGTON, June 18 -- Food and Drug Administration has issued a rule called: Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers.

The rule was published in the Federal Register on June 18 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, we, or the Agency) is publishing an order setting forth the Agency's final determination to exempt certain class II clinical electronic thermometers from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for such class II clinical electronic thermome...