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Endotoxin assays to Class II

This article was originally published in The Gray Sheet

Executive Summary

Endotoxin activity assay manufacturers should include a risk analysis study in premarket notifications to guard against falsely low or high toxin readings, FDA says in a final rule downclassifying the assays from Class III to Class II with special controls. The agency cites "failure of endotoxin tests to perform as indicated or error in interpretation of results" as the primary threat to proper patient management (1"The Gray Sheet" Aug. 11, 2003, p. 19). The rule, published in the Oct. 31 Federal Register, takes effect Dec. 1...
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