PMC

There are seven categories that devices need to score a 1 in to obtain a CLIA-waiver (1 = lowest complexity, 3 = highest complexity). Each box describes the requirements for a device to score a 1 in the different categories.

Performing a clinical needs assessment should result in a clinically relevant test menu that users would prefer to have on POC devices. It would also show that they prefer the POC devices to be small and handheld, require no sample processing, alert the user of critical values, and wirelessly communicate the results. This information would go to device developers to produce CLIA-waived technology with these capabilities that are usable in homes, hospitals, clinics, ambulances, and alternate care facilities. The devices produced will assist in new clinical needs assessments through user feedback.