FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; EXEMPTIONS FROM PREMARKET NOTIFICATION: CLASS II DEVICES; CERTAIN CLINICAL TOXICOLOGY TEST SYSTEMS

WASHINGTON, Oct. 6 -- Food and Drug Administration has issued a rule called: Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems.

The rule was published in the Federal Register on Oct. 6 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k) requirements, subject to certain limitations, is immediately in effect for such devices. This exemption will decrease regulato...