Assay migration studies draft guidance
This article was originally published in The Gray Sheet
Executive Summary
AdvaMed, Gen-Probe and Siemens are among stakeholders seeking greater flexibility in statistical analysis methods than what FDA says is acceptable in draft guidance on "Assay Migration Studies for In Vitro Diagnostic Devices." Comments were due April 6 on the document, which describes an accelerated path to getting an already-marketed assay approved on a new platform. It primarily targets Class III assays marketed via a premarket approval application or biologics license application, both of which typically require clinical validation data (1"The Gray Sheet" Jan. 12, 2009, p. 13)