Medical Devices; Reports of Corrections and Removals

The Food and Drug Administration (FDA) is issuing a final rule to establish procedures for implementing the reports of corrections and removals provisions of the Safe Medical Devices Act of 1990 (the SMDA) by requiring that manufacturers, importers, and distributors report promptly to FDA any corrections or removals of a device undertaken to reduce a risk to health posed by the device or to remedy a violation of the Federal Food, Drug, and Cosmetic Act (the act) caused by the device which may present a risk to health. FDA believes that this action is necessary to protect the public health by ensuring that the agency has current and complete information regarding those actions taken to reduce risks to health caused by the devices. Reports of such actions will improve the agency's ability to evaluate device-related problems and to take prompt action against potentially dangerous devices.