What this evidence supports
TEMPO is connected with ACCESS and is designed for participating manufacturers to collect, monitor, and report real-world data for intended uses under evaluation.
What it does not establish
Pilot participation is not FDA approval or proof of effectiveness. FDA states that effectiveness for the participating intended uses has not yet been evaluated.
Answer-ready summary
TEMPO is designed to connect FDA oversight with prospective real-world evidence collection for selected devices used in ACCESS; FDA has not yet evaluated effectiveness for the participating intended uses.
Record details
- Decision priority
- Watch
- Current status
- Active pilot · four participants currently listed · effectiveness not yet evaluated by FDA
- Evidence tracks
- Technologies/care models · Implementation/adoption
- Source authority
- Primary/authoritative
- Source organization
- FDA
- Evidence design
- Federal regulatory pilot
- Applicability
- Applicable to decisions about the stated program, policy, standard, or development context; not evidence of clinical benefit beyond the cited scope.
- Confidence for the stated claim
- High
- Freshness
- Current
- Record date
- 2026-07-22
- Source updated
- 2026-07-22
- Last verified
- 2026-09-03
- Review due
- 2026-10-03 or sooner if the cited source changes.
- Version
- 1.1
- Revision state
- Version 1.1 replaces operational language with source-bounded program-design wording, adds the current four-participant state and FDA's exact effectiveness limitation, and records the September 3, 2026 re-verification.
Evidence record fields
- Claim supported
- TEMPO is connected with ACCESS and is designed for participating manufacturers to collect, monitor, and report real-world data for intended uses under evaluation.
- Source type and design
- Federal regulatory pilot
- Population and setting
- Not a participant-level clinical-study population in this source type. The program, policy, regulatory, standards, or research context described by the cited source.
- Intervention/exposure and comparator
- Not evaluated as a comparative intervention or exposure in the cited administrative or program source. No comparator is reported for this source-bounded claim.
- Outcome or endpoint
- The program, policy, regulatory, standards, or development state stated in the claim supported; no clinical outcome is inferred.
- Follow-up duration
- No clinical follow-up duration is reported for this source-bounded claim.
- Effect estimate and uncertainty
- No clinical effect estimate is reported. No statistical uncertainty estimate is reported; uncertainty is bounded through the source scope and stated limitations.
- Harms/adverse events
- No harms or adverse-event analysis is reported for this source-bounded administrative or program claim.
- Missing data and attrition
- Not reported; this record does not analyze participant-level data. Not applicable or not reported; no longitudinal participant cohort is analyzed.
- Bias/limitations
- Pilot participation is not FDA approval or proof of effectiveness. FDA states that effectiveness for the participating intended uses has not yet been evaluated.
- Applicability/generalizability
- Applicable to decisions about the stated program, policy, standard, or development context; not evidence of clinical benefit beyond the cited scope.
- Funding/conflicts
- Funding or sponsorship is recorded only where the cited source and claim state it; otherwise it is not assessed in this record. No conflict-of-interest assessment is reported for this administrative or program-source record.
- Replication or corroboration
- The administrative or program claim is anchored to the cited authoritative source; independent clinical replication is not implied.
- Decision use
- Use as source-bounded context for Clinicians, Innovators, Health-system leaders, Policymakers; do not use as stand-alone evidence of safety, efficacy, coverage, endorsement, or scaled adoption.
- Last reviewed / review due
- Last reviewed 2026-09-03; review due 2026-10-03 or sooner if the cited source changes.
For this decision
Clinicians · Innovators · Health-system leaders · Policymakers