FDA SaMD 510(k)/De Novo evidence for legal AI workflows.
For general counsel and litigation support: use the self-serve API to gate the workflow and link the FDA SaMD 510(k)/De Novo requirement to the evidence record for the legal AI workflow under review.
What you get.
FDA SaMD 510(k)/De Novo in ATTESTATION.json
Every artifact your legal AI workflow emits is hashed and named; the FDA SaMD 510(k)/De Novo control reference sits next to the hash.
Law anchors named alongside
The evidence record names FRE 702 · ABA Model Rules together. Internal or external law compliance sees the regime they care about, not a generic list.
Bit-exact on your hardware
The measurement engine runs in-enclave. Law evidence rules can permit recompute on customer infrastructure; the record supports that review property by construction.
Related coverage.
FDA SaMD 510(k)/De Novo reference · Open the FDA SaMD 510(k)/De Novo reference · FDA SaMD 510(k)/De Novo capability brief · Law vertical landing
Every law-shaped landing for the corpus lives under register 09.
See the Legal evidence workflow path in the Console.
Open the Console to see sealed records; the Docs carry the endpoints.