What this evidence supports
TEMPO connects FDA oversight with real-world evidence generation for selected devices used in ACCESS.
What it does not establish
Pilot participation is not FDA approval or proof of effectiveness for the evaluated intended use.
Record details
- Source authority
- FDA
- Evidence level
- E5
- Directness
- 5/5
- Recency
- 5/5
- Decision relevance
- 5/5
- Date
- 2026-07-22
Primary source
Related intelligence
FDA TEMPO selects Dexcom as first participant linked to CMS ACCESS