QIBA for Regulators
QIBA Mission: Improve the value and practicality of quantitative imaging biomarkers by reducing variability across devices, sites, patients, and time.
QIBA develops Profile documents that standardize methods for creating a specific biomarker with predictable performance (accuracy and reproducibility).
Medical Device Regulators benefit from QIBA through:
- Profile documents that include device and user tasks necessary to achieve a specific quantitative imaging performance claims
- Conformance testing that can be used by device developers with consensus test and analysis methods for standardized assessment of image acquisition systems and quantitative imaging devices
- Development of datasets that can be used by device developers to standardize assessment of image acquisition systems and quantitative imaging devices
Medical Device Regulators can use QIBA:
- To understand consensus approaches for evaluating specific quantitative imaging device claims
- To communicate current thinking from the quantitative imaging community to medical device developers on test procedures and statistical analysis methods
- To potentially serve as a resource for device developers in conducting their own conformance testing in to support a regulatory submission
- As a source for phantom designs or image data to support quantitative imaging device assessment
(Like Keven's for Vendors, A bit of graphics/color would be nice - Maybe something from FDA which look regulatory in some way. One thought might be to use regulatory logos (FDA logo isn't copyrighted) something like this