What this evidence supports
FDA maintains a non-comprehensive, periodically updated public list identifying AI-enabled medical devices authorized for marketing in the United States.
What it does not establish
The list is explicitly non-comprehensive and periodically updated. Inclusion means FDA identified the device as AI-enabled and authorized it for marketing; omission proves neither lack of authorization nor lack of AI functionality, and inclusion does not establish comparative effectiveness, superiority, real-world performance, or adoption.
Answer-ready summary
FDA's non-comprehensive AI-enabled-device list is a periodically updated baseline of devices FDA identifies as AI-enabled and authorized for marketing; omission does not establish lack of authorization.
Record details
- Decision priority
- Watch
- Current status
- Current non-comprehensive FDA authorization-list resource · periodically updated
- Evidence tracks
- Technologies/care models · Science/market
- Source authority
- Primary/authoritative
- Source organization
- FDA
- Evidence design
- Federal authorization landscape
- 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
- 2026-06-16
- Source updated
- 2026-06-16
- 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 corrects the record date to FDA’s June 16, 2026 content-current date, adds the list’s non-comprehensive and periodically updated semantics, strengthens inclusion/omission limits, and records the September 3, 2026 re-verification.
Evidence record fields
- Claim supported
- FDA maintains a non-comprehensive, periodically updated public list identifying AI-enabled medical devices authorized for marketing in the United States.
- Source type and design
- Federal authorization landscape
- 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
- The list is explicitly non-comprehensive and periodically updated. Inclusion means FDA identified the device as AI-enabled and authorized it for marketing; omission proves neither lack of authorization nor lack of AI functionality, and inclusion does not establish comparative effectiveness, superiority, real-world performance, or adoption.
- 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, Public/patients; 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 · Public/patients