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ENT endoscopic sheath barrier claims should be based on 30 nm or smaller virus size, FDA says.

This article was originally published in The Gray Sheet

Executive Summary

EAR, NOSE AND THROAT ENDOSCOPE SHEATH PROTECTIVE BARRIER CLAIMS should be based on tests that include a barrier challenge from a pathogenic organism as small as the hepatitis A virus, FDA says in an Oct. 21 premarket notification guidance document. The guidance states that "in order for the test to be used to demonstrate safety with regard to human pathogens, the test virus should be as small as the hepatitis A virus (30 nm diameter), one of the smallest human pathogenic viruses."
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