Current published FDA paperFDA CDRH log: August 20, 2026Checked September 3, 2026
FDA sets out fit-for-purpose considerations for digitally derived measures in clinical investigations
FDA’s medical-product centers jointly published a paper drawing from existing FDA guidances. It describes digitally derived measures as measures derived from digital-health-technology data and says they may serve as clinical outcome assessments, biomarkers, or part of multicomponent endpoints.
What the source supports
For a digital health technology used to generate a measure in a clinical investigation, the paper identifies verification, analytical and clinical validation, usability and human factors, clinically relevant and patient-meaningful concepts, and potential sources of error as key considerations.
What it does not establish
The paper does not qualify a particular measure or establish the safety, effectiveness, authorization, coverage, reimbursement, or adoption of a technology or intervention. Fit for purpose remains specific to the intended context and supporting evidence.
Decision use: define the concept of interest and context of use, then test the evidence plan before treating a sensor output as a defensible endpoint.
Completed event · post-event materials available · P4L review pendingEvent August 27, 2026Checked September 3, 2026
FDA workshop examines statistical considerations for digitally derived endpoints
FDA hosted and Duke-Margolis convened a completed virtual public workshop on digitally derived endpoints in drug and biological-product clinical trials. The posted agenda covers regulatory efforts, continuous glucose monitoring technical specifications, measurement and validation, data provenance, missing data, statistical analysis, and future considerations.
Material now available
The Duke-Margolis event page provides the agenda, speaker biographies, a 192-page event slide deck, and an embedded recording. Their availability supersedes the earlier materials-pending watch state.
What remains limited
An agenda, presentation, or panel remark is not automatically a consensus finding, new FDA guidance, or a product-specific endpoint-acceptance decision. Duke-Margolis states that the FDA-funded event materials do not necessarily represent official FDA or HHS views or endorsement. Detailed synthesis requires speaker-level attribution and review against the posted materials.
Program milestone · clinical evidence pendingPublished August 11, 2026Checked September 3, 2026
XPRIZE Healthspan advances 20 finalist teams; 10 receive $1 million milestone awards
XPRIZE announced 20 finalist teams and named 10 of those finalists as Milestone 2 Awardees receiving $1 million each. XPRIZE says finalists are expected to conduct coordinated clinical trials through 2029 involving adults aged 50 to 90 and measures of muscle, cognition, and immune function.
What the milestone does not establish
Finalist or award status is not evidence of safety, efficacy, clinical benefit, regulatory status, endpoint validity, coverage, reimbursement, scalability, accessibility, or generalizability. The next decision-relevant evidence begins with protocols, registered outcomes, comparators, follow-up, harms, attrition, effect estimates, and independent review.