FDA-Medical-Device-Regulatory-Framework
Rs · Resource
Individual
http://proethica.org/ontology/case/150#FDA-Medical-Device-Regulatory-Framework
Properties
Instance of
MedicalDeviceSafetyRegulatoryFramework
http://proethica.org/ontology/intermediate#MedicalDeviceSafetyRegulatoryFramework
Confidence
0.88
Created by
U.S. Food and Drug Administration / U.S. Congress
Document title
Federal Medical Device Safety Regulatory Framework (e.g., FDA 21 CFR Part 803 Medical Device Reporting)
Importance
high
Used by
Engineer A as the external reporting authority he will invoke if the manager does not act promptly
Used in context
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 case150: <http://proethica.org/ontology/case/150#> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix proeth: <http://proethica.org/ontology/intermediate#> .
@prefix prov: <http://www.w3.org/ns/prov#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
case150:FDA-Medical-Device-Regulatory-Framework a proeth:MedicalDeviceSafetyRegulatoryFramework,
owl:NamedIndividual ;
rdfs:label "FDA-Medical-Device-Regulatory-Framework" ;
proeth:conceptCategory "Resource" ;
proeth:confidence "0.88" ;
proeth:createdby "U.S. Food and Drug Administration / U.S. Congress" ;
proeth:discoveredincase "150" ;
proeth:discoveredinpass "1" ;
proeth:discoveredinsection "facts" ;
proeth:documenttitle "Federal Medical Device Safety Regulatory Framework (e.g., FDA 21 CFR Part 803 Medical Device Reporting)" ;
proeth:firstdiscoveredat "2026-02-28T14:29:05.582238+00:00" ;
proeth:firstdiscoveredincase "150" ;
proeth:generatedattime "2026-02-28T14:29:05.582238+00:00" ;
proeth:importance "high" ;
proeth:resourceclass "Medical Device Safety Regulatory Framework" ;
proeth:sourcetext "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" ;
proeth:textreferences "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" ;
proeth:usedby "Engineer A as the external reporting authority he will invoke if the manager does not act promptly" ;
proeth: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." ;
proeth:version "Current federal regulations" ;
proeth:wasattributedto "Case 150 Extraction" ;
prov:generatedAtTime "2026-02-28T14:52:22.189867"^^xsd:dateTime ;
prov:wasGeneratedBy "ProEthica Case 150 Extraction" .
Metadata
Extraction details
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