Medical Devices; Reclassification of 28 Preamendments Class III Devices into Class II

The Food and Drug Administration (FDA) is reclassifying 28 preamendments devices from class III (premarket approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997. The agency is also revising the identification of six of the devices subject to this rule to more accurately reflect the characteristics of devices actually being marketed. FDA is withholding action on 11 devices, which the agency proposed to reclassify, pending further action.