Regulation — healthcare-specific
FDA PCCP — Predetermined Change Control Plan for AI-inclusive devices
If your clinical AI is or uses an FDA-cleared device, the PCCP defines the envelope of modifications allowed without a new 510(k). Drift outside that envelope triggers reporting obligations under 21 CFR 803 (MDR) plus potential recall exposure.
What the guidance actually says
"A PCCP describes the planned modifications to the device that the manufacturer intends to implement … the associated methodology to develop, validate, and implement those modifications … and an assessment of the impact of those modifications."
FDA Guidance: Marketing Submission Recommendations for a PCCP for AI/ML-Enabled Device Software Functions (2023 draft, referenced in ongoing rulemaking)
"Manufacturers must submit MDR reports to FDA no later than 30 calendar days after becoming aware … that a device may have caused or contributed to a death or serious injury … or has malfunctioned and would be likely to cause or contribute if it were to recur."
21 CFR 803.50 (MDR reporting for manufacturers) — the escalation trigger
What this means in plain English
Two obligations chain together:
- The AI device's behavior in production must stay inside the pre-approved PCCP envelope. Silent drift of group-differential magnitude may fall outside that envelope.
- Once a hospital knows (or should know) the device malfunctioned in a way that could contribute to serious injury, the manufacturer's MDR clock starts — and the hospital's own reporting obligations under 21 CFR 803.30 (user facility) may run in parallel.
Hospitals often assume "the vendor handles FDA." User-facility MDR obligations are hospital-side, and they trigger on hospital-side knowledge.
What triggers the exposure in the sample
A 34-percentage-point group-differential drift in urgent-lane routing is not standard PCCP-envelope drift. It is behavior the pre-market submission almost certainly did not contemplate at that magnitude for the elderly-multimorbid subpopulation. The moment the hospital knows, the MDR user-facility clock is a live question.
What the $499 Snapshot shows against this rule
- Timestamped drift-detection evidence (first-drift-day + severity trajectory) — the "when did the hospital know" record
- Patient group-level detail sufficient to characterize likely serious-injury contribution
- Model-version pinning — the exact device-software-function version the drift attaches to
- Independent-verifier signature — supports the good-faith position that the hospital investigated
See the drift-detection chart →
$499 Snapshot. 3 business days.
Independent evidence of when the hospital learned + what the pattern looked like. The timeline record that documents the good-faith investigation stance.
Buy $499
Snapshot credit applies to Baseline ($2,500) or Enterprise Attestation ($35-55K) upgrade within 30 days.