Zdrowie i gospodarka · 14/08/1995

Order for Certain Class III Devices; Submission of Safety and Effectiveness Information

The Food and Drug Administration (FDA) is issuing an order requiring manufacturers of 27 class III devices to submit to FDA a summary of, and a citation to, all information known or otherwise available to them respecting such devices, including adverse safety or effectiveness information concerning the devices which has not been submitted under the Federal Food, Drug, and Cosmetic Act (the act). FDA is requesting this information in order to determine, for each device, whether the classification of the device should be revised, or whether a regulation requiring the submission of premarket approval applications (PMA's) for the device should be promulgated. Based on preliminary information, FDA believes these 27 devices are not likely candidates for reclassification and, therefore, will likely require the submission of PMA's sometime in the future.