📋 FDA AI/ML SaMD Predetermined Change Control Plan Simulator

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.