Medical Devices; Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications, [510(k)], to FDA; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications, [510(k)], to FDA.'' The guidance document provides suggestions for the nonclinical laboratory studies and the design, conduct, and analysis of appropriate clinical studies that the Center for Devices and Radiological Health (CDRH), FDA, believes will provide reasonable assurance of the safety and effectiveness of these devices. The guidance document also sets forth the review criteria and describes the data to support a 510(k) submission. The guidance accompanies a final rule, which appears elsewhere in this issue of the Federal Register, announcing the reclassification of tumor associated antigen immunological test systems from class III (premarket approval) to class II (special controls).