FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: MEDICAL DEVICES WITH INDICATIONS ASSOCIATED WITH WEIGHT LOSS-PREMARKET CONSIDERATIONS; GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, March 13 -- Food and Drug Administration has issued a notice called: Medical Devices With Indications Associated With Weight Loss-Premarket Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on March 13 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Medical Devices with Indications Associated with Weight Loss-Premarket Considerations." This guidance document provides recommendations regarding non-clinical testing and clinical study design for medical devices with indications fo...