HEMODIALYZER 510(K) GUIDANCE DUE OUT BY END OF YEAR
This article was originally published in The Gray Sheet
Executive Summary
HEMODIALYZER 510(K) GUIDANCE DUE OUT BY END OF YEAR, according to FDAers. The hemodialyzer 510(k) guidance, a different document than the hemodialyzer reuse labeling guidance under development at the agency, will update a 1982 document that FDA believes does not adequately address current dialysis technology.