Under Review
v1.0.4-LATEST
Premarket Approval
Architectural Definition
The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Schema Preview
● application/json
{
"entity": "premarket-approval",
"domain": "pharmacy",
"metadata": {
"displayName": "Premarket Approval",
"status": "DRAFT",
"version": "1.0.4",
"isStandardized": false
}
}Standard
ISO-8601
Data Type
String/Obj
Steward
Arch Council
Verified
Feb 2026