Can I update my AI model after 510(k) clearance without a new submission?
Yes, if the change falls within an FDA-authorized PCCP cleared with your device — modifications inside the predetermined protocol can be made without a new 510(k); changes outside it generally still require a new submission. The PCCP is what buys that…
Answer.
Yes, if the change falls within an FDA-authorized PCCP cleared with your device — modifications inside the predetermined protocol can be made without a new 510(k); changes outside it generally still require a new submission. The PCCP is what buys that flexibility. Planisphere helps by producing reproducible drift evidence showing whether updates stayed within the plan's bounds; the regulatory determination of what needs a new submission is FDA's and your regulatory team's.
The mark behind the answer.
Predetermined Change Control Plan · drift-bounded model updates.
More on FDA PCCP.
Prepare evidence for FDA PCCP review.
First evidence record within 21 days of access · re-runs in a single business day. Planisphere measures model behaviour and emits a reproducible, sha-pinned record — it does not certify, file, or give legal advice.