Assayed Quality Control IVD Materials Eligible For Abbreviated 510(k)s
This article was originally published in The Gray Sheet
Executive Summary
Manufacturers of assayed quality control materials for in vitro diagnostics (IVDs) should test non-human against human matrices to ensure that non-human materials, such as animal blood or urine, are sensitive to the same conditions as human-derived samples, according to an FDA guidance released Dec. 9.