Why it matters
This is a dated historical observation. Use the maintained FDA participant table for present-state participation.
Decision implication
For current TEMPO participation, use and timestamp the maintained FDA table. A historical observation does not establish why a source later changed.
For this decision
Clinicians · Innovators · Health-system leaders · Policymakers
Record details
- Current status
- Historical observation
- Decision priority
- Historical
- Source authority
- Primary/authoritative
- Evidence design
- Program record
- Applicability
- Direct
- Confidence for the stated claim
- High
- Freshness
- Historical
Evidence and sources
- https://www.fda.gov/medical-devices/digital-health-center-excellence/participants-selected-tempo-digital-health-devices-pilot
- https://www.cms.gov/priorities/innovation/access-model-accepted-applicants
This is a dated P4L observation. No archived FDA snapshot is attached, and the August 11 two-participant state cannot be independently reproduced from the current maintained table. This dated observation does not replace the maintained FDA participant table and does not establish why the source later changed. FDA states that effectiveness for the participating intended uses has not yet been evaluated.
Current record
FDA TEMPO maintained participant table lists four participants.
What P4L is watching next
- New FDA TEMPO participant additions or removals
- changes to intended uses
- FDA participant-table changes
- ACCESS applicant/participant status changes
Record provenance
- Last verified
- 2026-08-11
- Revision state
- Version 3.2 adds FDA's exact effectiveness limitation, removes an unsupported FDA source-update date, and discloses that no archived FDA snapshot is attached; August 11, 2026 remains P4L's dated observation and verification.
- Version
- 3.2
- Stable ID
- SIG-2026-002