FDA-Medical-Device-Regulatory-Framework
Individual
63db4b88
http://proethica.org/ontology/case/150#FDA-Medical-Device-Regulatory-Framework
Properties
Parent
MedicalDeviceSafetyRegulatoryFramework
http://proethica.org/ontology/intermediate#MedicalDeviceSafetyRegulatoryFramework
Concept Category
Resource
Confidence
0.88
Createdby
U.S. Food and Drug Administration / U.S. Congress
Documenttitle
Federal Medical Device Safety Regulatory Framework (e.g., FDA 21 CFR Part 803 Medical Device Reporting)
Importance
high
Resourceclass
Medical Device Safety Regulatory Framework
Usedby
Engineer A as the external reporting authority he will invoke if the manager does not act promptly
Usedincontext
Provides the legal mechanism and authority to which Engineer A threatens to report the unresolved infant respirator defect, establishing the external regulatory accountability that compels manufacturer action when internal escalation fails.
Version
Current federal regulations
Source Evidence
Source Text
Engineer A indicates that if prompt measures are not taken to correct the problem, he will be compelled to report the matter to an appropriate federal regulatory agency
Text References
Engineer A indicates that if prompt measures are not taken to correct the problem, he will be compelled to report the matter to an appropriate federal regulatory agency
TTL
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix proethica_case_150: <http://proethica.org/ontology/case/150> .
<http://proethica.org/ontology/case/150#FDA-Medical-Device-Regulatory-Framework> a owl:NamedIndividual ;
rdfs:label "FDA-Medical-Device-Regulatory-Framework" ;
rdfs:subClassOf <http://proethica.org/ontology/intermediate#MedicalDeviceSafetyRegulatoryFramework> .
Metadata
Ontology
Type
Individual
Content Hash
63db4b8847023875...Last Updated
2026-03-08 16:29
Extraction Provenance
Discovered in Case
150
Discovered in Pass
1
Discovered in Section
facts
First Discovered
2026-02-28T14:29:05.582238+00:00
First Case
150
Generated
2026-02-28T14:29:05.582238+00:00
Attributed To
Case 150 Extraction
Generated
2026-02-28T14:52:22.189867
Generated By
ProEthica Case 150 Extraction