This article was originally published in The Gray Sheet
510(k)s for conventional (21 CFR 876.5820) and high-permeability (21 CFR 876.5860) hemodialyzers that have "new" membrane material or employ a design that is "significantly different" from the predicate device should include clinical data "collected on a minimum of 12 patients for a minimum of 36 treatments," FDA says in a guidance document posted Sept. 23 on its website (www.fda.gov/cdrh). For hemodialyzers labeled "single use only," clinical data "on a minimum of 12 patients" should be included to "clarify the relationship between the ultrafiltration data obtained from the in vitro tests and the expected clinical performance of the hemodialyzer," the agency says
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