Filing the Device Together With Its Change Plan
The initial submission bundles the locked model with a plan.
- 3: PCCP components (types, protocol, impact assessment)
- Periodic retrain: Typical change type (scheduled data refresh)
- 510(k) / De Novo / PMA: Submission pathway (device-dependent)
- Yes: Boundary defined at filing (pre-specified, not ad hoc)
What a PCCP actually specifies
Short placeholder covering anticipated modification types and their limits.
FDA Authorizes Device and Boundary Together
Reviewers evaluate the model and its future-change envelope as one unit.
- Device + PCCP: Review scope (single authorization event)
- Corridor: Boundary output (pre-agreed performance envelope)
- Locked: Modification protocol (defines retrain method/data)
- Required: Impact assessment (benefit-risk of allowed changes)
Why the boundary is locked at this stage
Short placeholder on how the corridor becomes the controlling envelope.
Retraining Within the Pre-Authorized Envelope
The manufacturer proposes a model change sized by real-world data drift.
- New training data: Trigger (periodic or performance-driven)
- Retrain / recalibrate: Change types (per locked protocol)
- Small → major: Magnitude range (tweak to architecture change)
- Manufacturer-led: Governance (within PCCP protocol)
Sizing an update against the envelope
Short placeholder on how proposed magnitude compares to the corridor.
Checking Each Update Against Pre-Set Criteria
Performance metrics are re-verified before any update reaches patients.
- Pre-specified criteria: Verification basis (set during authorization)
- No, if within bounds: New submission needed (core PCCP benefit)
- Update report: Documentation (evidence of bound compliance)
- Full submission: Failure path (if criteria not met)
Pass/fail at the verification gate
Short placeholder describing the in-bounds versus out-of-bounds check.
Agile Iteration Inside a Controlled Envelope
PCCP enables fast updates while keeping every change inside agreed limits.
- Deploy: Within bounds (no new full submission)
- Resubmit: Exceeds bounds (new full regulatory review)
- Agile + controlled: Net effect (speed without open-ended risk)
- New PCCP needed: Boundary revision (to expand scope later)
Why the envelope matters more than any single update
Short placeholder on sustained control across many future updates.
Short placeholder: the corridor, not any one update, is the real control.