Zdrowie i gospodarka · 05/01/2009

FDA Releases Draft Guidance for Industry and Food and Drug Administration Staff on Assay Migration Studies for In Vitro Diagnostic Devices

The Food and Drug Administration (FDA) has released a draft guidance document titled "Assay Migration Studies for In Vitro Diagnostic Devices," which outlines a streamlined approach for obtaining FDA approval for certain in vitro diagnostic devices that are transitioning to a new system.