Assay Migrations: FDA Offers Streamlined Path To Switch Testing Platforms
This article was originally published in The Gray Sheet
Executive Summary
In an age of ever-accelerating automation, making lab tests available on new instrument platforms is a natural evolutionary step in the clinical diagnostics space. FDA issued draft guidelines Jan. 5 to help companies make these transitions while minimizing developmental burdens
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Assay migration studies draft guidance
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are among stakeholders seeking greater flexibility in statistical analysis methods than what FDA says is acceptable in draft guidance on "Assay Migration Studies for In Vitro Diagnostic Devices."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)
Assay migration studies draft guidance
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are among stakeholders seeking greater flexibility in statistical analysis methods than what FDA says is acceptable in draft guidance on "Assay Migration Studies for In Vitro Diagnostic Devices."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)