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In Brief: Tumor marker downclassification

This article was originally published in The Gray Sheet

Executive Summary

Tumor marker downclassification: FDA announces availability of its "Guidance Document for the Submission of Tumor Associated Antigen Pre-Market Notifications, 510(k) to FDA" in the Dec. 17 Federal Register. The agency also codifies in a separate announcement the downclassification of tumor markers used as "an aid in monitoring patients for disease progression or response to therapy or for the detection of recurrent or residual disease" from Class III to Class II ("The Gray Sheet" Sept. 23, 1996, I&W-1). The regulation appears in 21 CFR Section 866.6010...

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