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Vasca

This article was originally published in The Gray Sheet

Executive Summary

FDA deems LifeSite hemodialysis access system revised labeling acceptable. Vasca reports receiving an Aug. 12 communication from the agency determining the firm's response to a November 2001 warning letter to be satisfactory. FDA originally requested that the Tewksbury, Massachusetts firm update labeling to reflect postmarket adverse event rates associated with off-label use of the device in unevaluated body sites and in certain patient populations (1"The Gray Sheet" Jan. 7, 2002, p. 9)...
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