Why it matters
The correction matters because ACCESS applicant status and TEMPO participant status are distinct program facts. P4L must reverify dynamic source tables and keep cross-program identity transfers from becoming downstream claims.
Decision implication
Use the FDA participant table—not ACCESS applicant status—to establish TEMPO participation, and reverify the table before consequential use.
Who or what is affected
- FDA
- CMS Innovation Center
- Dexcom
- Cadence Health ACCESS accepted applicants
- ACCESS organizations
Evidence and sources
E5 — official federal source
- https://www.fda.gov/medical-devices/digital-health-center-excellence/participant-selected-tempo-digital-health-devices-pilot
- https://www.cms.gov/priorities/innovation/access-model-accepted-applicants
What P4L is watching next
- New FDA TEMPO participant additions
- changes to intended uses
- FDA participant-table changes
- ACCESS applicant/participant status changes
Related proof records
Record provenance
- Last verified
- 2026-08-11
- Version
- 2.0
- Stable ID
- SIG-2026-002