Order for transitional class III devices; submission of safety and effectiveness information under section 520(1)(5)(A) of the Federal Food, Drug, and Cosmetic Act--FDA. Notice

The Food and Drug Administration (FDA) is issuing an order requiring manufacturers of transitional class III devices to submit to FDA a summary of, and a citation to, any information known or otherwise available to the manufacturers respecting the devices, including adverse safety or effectiveness information which has not been submitted under section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i). This is the first step in the process of determining the appropriate classification of transitional devices under the Safe Medical Devices Act of 1990.