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FDA AI-Enabled Medical Devices: Procurement Guide for Provider Groups (2026)

AI procurement in healthcare is increasingly a regulatory diligence exercise. This guide helps enterprise buying teams evaluate whether vendor claims are supported by the right FDA pathway, documentation, and post-market change controls.

What to Verify First

  • Whether the product appears on FDA’s AI-enabled medical device list.
  • What pathway was used (510(k), De Novo, PMA) and for what intended use.
  • Whether vendor claims exceed labeled indications or validated use conditions.
  • How updates are managed and whether a PCCP approach is in scope.

PCCP Matters for Enterprise Buyers

FDA’s final PCCP guidance for AI-enabled device software functions (issued in August 2025) gives a structure for planned modifications, validation methodology, and impact assessment. Even when you are not the manufacturer, this should shape your contract language and governance expectations around updates.

Procurement Checklist for CIO/CMIO/Compliance Teams

Regulatory packet

  • FDA authorization/clearance references and indications-for-use mapping
  • Validation cohort characteristics and performance evidence
  • Known limitations and failure-mode documentation

Operational packet

  • Integration architecture and workflow insertion points
  • Alert governance and override capture
  • Downtime fallback and incident escalation procedures

Commercial packet

  • Update cadence and notification commitments
  • Change-control obligations for model revisions
  • Data rights, retention rules, and exit/export conditions

Red Flags During Vendor Demos

  • Marketing claims that are broader than FDA-labeled use.
  • No clarity on how real-world drift is monitored.
  • No documented rollback criteria for degraded performance.
  • Update process that bypasses buyer governance.

Contract Terms to Require

  • Advance notice windows for model changes and release notes
  • Performance monitoring obligations and escalation thresholds
  • Audit support for incidents involving model behavior
  • Explicit obligations for clinical safety communications

Primary Sources

Next Steps