Daniel M Krainak & Robert Ochs
Food and Drug Administration, USA
Title: FDA/CDRH perspectives on imaging biomarkers: Technical performance and analytical validation
Biography
Biography: Daniel M Krainak & Robert Ochs
Abstract
The Center for Devices and Radiological Health has responsibility for radiological device pre-market reviews and participates in biomarker qualification review teams for imaging biomarkers through the Medical Device Development Tools program (CDRH) and the Biomarker Qualification Program (CDER). CDRH’s perspective on the evidentiary approach to quantitative imaging devices and imaging biomarkers will be presented. A regulatory perspective on the interaction between claims and analytical validation expectations will be explored for radiological imaging devices. Combinations of technical performance assessments including combinations of physical phantoms, digital reference objects and in vivo imaging may be used to approach analytical validation of imaging devices. Differing evidentiary expectations will be presented with examples. Research within CDRH continues to refine and expand the available methods for assessing the performance of quantitative imaging biomarkers.