Policy statement; class II medical devices--FDA. Notice

The Food and Drug Administration (FDA) is announcing its policy for setting priorities for initiating proceedings to establish performance standards for medical devices classified into class II, a category of devices under the Medical Device Amendments for which FDA is required to establish performance standards. At this time, however, FDA does not have the resources to establish performance standards for all class II devices. Accordingly, the policy describes the factors the agency takes into account in establishing priorities for initiating standard-setting proceedings.