Fingerstick
Needs and Opportunities (Problem/Challenge): Need for scientifically sound and practical study design recommendations when evaluating analytical performance characteristics of POC devices using capillary whole blood specimens.
Vision (Solutions):
Develop and define clear analytical validity study designs for Point of Care devices (quantitative and qualitative) that use fingerstick capillary blood specimens.
Value to Stakeholders:
- Patients: Expedited access to less invasive and more accessible diagnostic medical device technologies
- Industry: Decrease time and cost of analytical testing for POC devices which use fingerstick capillary blood specimens
- FDA/CDRH:
- Support CDRH’s mission to maintain US leadership in medical device innovation and expedited patient access to new technologies
- Improved data quality for regulatory submissions that include capillary samples