IVDs SHOULD BE VALIDATED IN GROUPS BY LIKE FORMULATION
This article was originally published in The Gray Sheet
Executive Summary
IVDs SHOULD BE VALIDATED IN GROUPS BY LIKE FORMULATION, rather than individually, when assessing a product's accuracy, purity and specificity, the Health Industry Manufacturers Association suggests in April 8 comments on the final draft of FDA's "Guideline for the Manufacture of In Vitro Diagnostic Products." Noting that the latest draft requires prospective validation of each new in vitro diagnostic product, HIMA says the guideline "does not recognize the fact that many formulations are identical in the way that they support (or inhibit) microbial growth."