{
  "description": "Additional codes found on https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event#:~:text=Required%20Intervention%20to%20Prevent%20Permanent%20Impairment%20or%20Damage%20(Devices),use%20of%20a%20medical%20product. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch).",
  "_filename": "CodeSystem-fda-add-seriousness-criteria-cs.json",
  "package_name": "hl7.fhir.uv.ae-research-backport-ig",
  "date": "2023-07-28T19:53:38+00:00",
  "publisher": "HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups",
  "jurisdiction": [ {
    "coding": [ {
      "code": "001",
      "system": "http://unstats.un.org/unsd/methods/m49/m49.htm"
    } ]
  } ],
  "content": "complete",
  "name": "FDAaddSeriousnessCriteriaCS",
  "type": null,
  "experimental": "true",
  "resourceType": "CodeSystem",
  "title": "FDA Additional Seriousness Criteria CodeSystem",
  "package_version": "1.0.0-ballot",
  "extension": [ {
    "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode": "informative",
    "_valueCode": {
      "extension": [ {
        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
        "valueCanonical": "http://hl7.org/fhir/uv/ae-research-backport-ig/ImplementationGuide/hl7.fhir.uv.ae-research-backport-ig"
      } ]
    }
  } ],
  "status": "draft",
  "id": "2e087383-61d6-4c96-b585-d4944e45f624",
  "kind": null,
  "count": 1,
  "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/fda-add-seriousness-criteria-cs",
  "concept": [ {
    "code": "requiresPreventImpairment",
    "display": "Required Intervention to Prevent Permanent Impairment or Damage (Devices)",
    "definition": "Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product"
  } ],
  "caseSensitive": true,
  "version": "1.0.0-ballot",
  "contact": [ {
    "name": "Biomedical Research and Regulation WG",
    "telecom": [ {
      "value": "http://hl7.org/Special/committees/rcrim",
      "system": "url"
    } ]
  } ]
}