U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Guidance Documents (Medical Devices and Radiation-Emitting Products)
  5. Submission of Tumor Associated Antigen Premarket Notifications, [510(k)], to Food and Drug Administration - Guidance Document for Industry
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Submission of Tumor Associated Antigen Premarket Notifications, [510(k)], to Food and Drug Administration - Guidance Document for Industry

Read the Special Controls Document

Issue Date: 09/19/1996

Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health

This document represents current FDA thinking and provides suggestions for 510 (k) submissions of Tumor Associated Antigen in vitro diagnostic devices employing immunochemistry methodology. It is based on 1) current basic science, 2) clinical experience, 3) the Safe Medical Device Act of 1990 and 4) FDA Code of Federal Regulations (CFR). As advances are made in science and medicine, these review criteria will be evaluated and revised as necessary.