Under Review
v1.0.4-LATEST
De Novo Pathway
Architectural Definition
A regulatory pathway for novel medical devices that are low-to-moderate risk but do not have a valid predicate device.
Schema Preview
● application/json
{
"entity": "de-novo-pathway",
"domain": "pharmacy",
"metadata": {
"displayName": "De Novo Pathway",
"status": "DRAFT",
"version": "1.0.4",
"isStandardized": false
}
}Standard
ISO-8601
Data Type
String/Obj
Steward
Arch Council
Verified
Feb 2026