CPTC Reagents Data Portal

Guidance Documents

Guidance documents are written guidelines that provide broad advice for following a procedure or process, rather than a set of precise requirements or standards.

The NCI-FDA Interagency Oncology Task Force (IOTF) was established in Spring 2007. The IOTF recognizes that proteomic approaches are an important emerging area for development of new in vitro diagnostics and as biomarkers for use in drug development.  Proteomic technologies have unique analytical issues that will require careful consideration and planning in order to demonstrate accurate and reliable performance prior to use in biomarker discovery/measurement or as diagnostic devices.  The “Mock 510K” will address scientific and regulatory challenges specific to identification and development of protein-based biomarkers for clinical use, and analytical validation issues specifically relating to technologies for measuring these protein markers, such as mass spectrometry and affinity capture methods.  These documents include discussion of sources of assay variability, selection of standards/quality control materials, application of internal and external control strategies, appropriate metrics for quality control, and instrument and assay performance analyses and metrics.