The FDA has issued an order requiring manufacturers of remaining preamendments class III devices for which regulations requiring submission of premarket approval applications (PMAs) have not been issued to submit to FDA certain safety and effectiveness information. Specifically, these manufacturers must submit a summary of, and a citation to, any available information respecting such devices, including adverse safety or effectiveness information, which has not been submitted under the Federal Food, Drug, and Cosmetic Act. The FDA is requiring the submission of this information to determine whether the classification of each device should be revised to require the submission of a PMA or a notice of completion of a Product Development Protocol, or whether the device should be reclassified into class I or II. The deadline for information submission is August 7, 2009.