FDA SaMD 510(k)/De Novo.
FDA SaMD 510(k)/De Novo can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. A team can use Planisphere's self-serve API to gate actions and retain a measurement record for internal or external compliance review; Planisphere does not certify compliance, perform the HIPAA risk analysis, or replace the safeguard system of record.
Reviewed 2026-07-08
What this is.
Use. clearance pathway for AI/ML device software functions.
Register. 09 · Compliance controls — one of the 17 registers of the PLANiSPHERE corpus library.
See it work.
Planisphere measures your tool deployment against FDA SaMD 510(k)/De Novo and seals the result into a signed, Merkle-rooted evidence record. The grade recomputes on your own hardware; the model state never crosses the boundary.
Promise. compliance
FDA SaMD 510(k)/De Novo can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. A team can use Planisphere's self-serve API to gate actions and retain a measurement record for internal or external compliance review; Planisphere does not certify compliance, perform the HIPAA risk analysis, or replace the safeguard system of record.
Answers: What evidence can Planisphere prepare for FDA SaMD 510(k)/De Novo review?
Questions this answers.
The board that carries this.
FDA SaMD 510(k)/De Novo (clearance pathway for AI/ML device software functions) asks for an evidence record: FDA SaMD 510(k)/De Novo can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. Read the related clinical AI workflow product context at /medicine.
CMS reg 09 · Medicare/Medicaid coverage · algorithm cannot be the sole basis to deny care DSI Source Attributes reg 09 · the 31 predictive-DSI source attributes as an evidence checklist FDA PCCP reg 09 · Predetermined Change Control Plan · drift-bounded model updates FDA PCCP / SaMD reg 09 · Predetermined Change Control · medical AI FSMB AI / state boards reg 09 · physician-responsibility · standard-of-care · state medical-board AI policySibling marks. Compliance controls
For each vertical.
FDA SaMD 510(k)/De Novo for defense AI workflow
NIST AI RMF · DoW RAI · OMB M-25-21 Open the pageFDA SaMD 510(k)/De Novo for clinical AI workflow
HHS §1557 · HIPAA · FDA PCCP Open the pageFDA SaMD 510(k)/De Novo for legal AI workflow
FRE 702 · ABA Model Rules Open the pageFDA SaMD 510(k)/De Novo for tutor and grader workflow
Title VI · FERPA · §504 / IDEA Open the pageSee the record FDA SaMD 510(k)/De Novo asks for.
The console shows the evidence; the docs show the endpoints; the briefing shows what the product does and does not claim.