medical product software development and fda regulations
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Medical Product Software Development and FDA Regulations
Software Development Practices and FDA Compliance
IEEE Orange County Computer SocietyMarch 27, 2006Carl R. Wyrwa
2
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Medical Product Software Development and FDA Regulations
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
3
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
The Intent Of Regulating Software
Patients
Operators Bystanders ServicePersonnel
Environment
Medical Device Safety and Efficacy
4
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
PeopleDoingThe Work
ReviewersInternal Auditors
External Reviewers
Many Stakeholders – Keeping A Total Solution In Mind
SafetyPatients
OperatorsBystanders
Service PeopleEnvironment Customer
andBusiness
Needs
QualitySystems
andQ&RA
MedicalPractitioners
AllNeeds
Met
5
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Many Stakeholders – Keeping A Balanced Solution In Mind
PeopleDoingThe Work
ReviewersInternal Auditors
External Reviewers
SafetyPatients
OperatorsBystanders
Service PeopleEnvironment
Customerand
BusinessNeeds
QualitySystems
andQ&RA
MedicalPractitioners
AllNeeds
Met
6
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
7
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Types of Regulated Software
Medical Device SoftwareSoftware that is actually a part of the medical device itselfSoftware that is an accessory to a medical deviceSoftware that itself is a medical device
8
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Types of Regulated Software
Medical Device SoftwareSoftware that is actually a part of the medical device itselfSoftware that is an accessory to a medical deviceSoftware that itself is a medical device
Non-Device Software that is part of:The production systemThe quality systemSystems that are used to create and maintain records required by FDA regulations
9
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
10
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
FDA Overview
FDA is a public health agency, charged with:protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws.
It is FDA's job to see that:the food we eat is safe and wholesome, the cosmetics we use won't hurt us, the medicines and medical devices we use are safe and effective, and that radiation-emitting products, such as microwave ovens, won't do us harm
One of our nation's oldest consumer protection agencies.Located in district and local offices in 157 cities across the country
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Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Medical Devices32,358
12
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
FDA Overview
Administrative Enforcement PowersUnannounced and Announced InspectionsInspectional Observations - 483Warning LettersAdverse PublicityFDA-Initiated Recalls and Monitoring Company-Initiated RecallsDelay, Suspension, or Withdrawal of Product ApprovalsPreclusion of Government contractsDetention and Refusal of Entry into U.S. Commerce of Imported Products
Judicial Enforcement PowersCivil Enforcement Powers (Seizure)Criminal Enforcement Powers (Prosecution)
13
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
14
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Medical Device Definition
Medical devices range from Simple Devices
Tongue depressors and bedpans
Complex DevicesProgrammable pacemakers
Laser surgical devices
Medical Device Classification – Class I, II, and IIIClass I devices include those with the lowest riskClass III devices includes those with the greatest risk.
15
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Medical Device Definition
• "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:• recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them, • intended for use in the diagnosis of disease or other conditions, or
in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals,
• and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
16
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
17
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
820.30 Design Control
820.30(a) General(1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall:
establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
(2) The following class I devices are subject to design controls:(i) Devices automated with computer software; and(ii) The devices listed ….. Below:
Catheter, Tracheobronchial SuctionGlove, Surgeon’sRestraint, ProtectiveSystem, Applicator, Radionuclide, ManualSource, Radionuclide Teletherapy
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Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software – Special Attention
General Principles of Software Validation3.3 Software Is Different From Hardware
“Because of its complexity, the development process for software should be even more tightly controlled than for hardware, in order to prevent problems that cannot be easily detected later in the developmentprocess”.
“……. software engineering needs an even greater level of managerialscrutiny and control than does hardware engineering”.
[1]
19
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
20
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Regulation of Software
21 CFR 807Establishment Registration
21 CFR 807Medical Device Listing
21 CFR 807Premarket Notification 510(k)
21 CFR 820Quality System Regulation
21 CFR 801Labeling
21 CFR 803Medical Device Reporting
21 CFR 814Premarket Approval PMA
Basic RegulatoryRequirements
21 CFR 820Quality System Regulation
A - General Provisions
B - Quality SystemRequirements
C – Design Controls
D – Document Controls
E – Purchasing Controls
F – Identificationand Traceability
G – Production & ProcessControls
H – Acceptance Activities
I – Nonconforming Product
J – Corrective & PreventiveAction (CAPA)
K – Labeling & PackagingControl
L – Handling, Storage,Distribution & Installation
M - Records
N - Servicing
O – Statistical Techniques
Quality System Regulation
C – Design Controls
820.30(a)General
820.30(b)Design & Development Planning
820.30(c)Design Input
820.30(d)Design Output
820.30(e)Design Review
820.30(f)Design Verification
820.30(g)Design Validation
820.30(h)Design Transfer
820.30(i)Design Changes
820.30 (j)Design History File
Design Controls
21
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Regulation of Software
21 CFR 807Establishment Registration
21 CFR 807Medical Device Listing
21 CFR 807Premarket Notification 510(k)
21 CFR 820Quality System Regulation
21 CFR 801Labeling
21 CFR 803Medical Device Reporting
21 CFR 814Premarket Approval PMA
Basic RegulatoryRequirements
21 CFR 820Quality System Regulation
A - General Provisions
B - Quality SystemRequirements
C – Design Controls
D – Document Controls
E – Purchasing Controls
F – Identificationand Traceability
G – Production & ProcessControls
H – Acceptance Activities
I – Nonconforming Product
J – Corrective & PreventiveAction (CAPA)
K – Labeling & PackagingControl
L – Handling, Storage,Distribution & Installation
M - Records
N - Servicing
O – Statistical Techniques
Quality System Regulation
820.70(a)General
820.70(b)Production & Process Changes
820.70(c)Environmental Control
820.70(d)Personnel
820.70(e)Contamination Control
820.70(f)Buildings
820.70(g)Equipment
820.70(h)Manufacturing Material
820.70(i)Automated Processes
Production & Process Controls
G – Production & ProcessControls
820.70(i)Automated Processes
22
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Regulation of Software
21 CFR 807Establishment Registration
21 CFR 807Medical Device Listing
21 CFR 807Premarket Notification 510(k)
21 CFR 820Quality System Regulation
21 CFR 801Labeling
21 CFR 803Medical Device Reporting
21 CFR 814Premarket Approval PMA
Basic RegulatoryRequirements
21 CFR 820Quality System Regulation
A - General Provisions
B - Quality SystemRequirements
C – Design Controls
D – Document Controls
E – Purchasing Controls
F – Identificationand Traceability
G – Production & ProcessControls
H – Acceptance Activities
I – Nonconforming Product
J – Corrective & PreventiveAction (CAPA)
K – Labeling & PackagingControl
L – Handling, Storage,Distribution & Installation
M - Records
N - Servicing
O – Statistical Techniques
Quality System Regulation
J – Corrective & PreventiveAction (CAPA)
820.100Corrective & Preventive Action
Quality SystemRequirements
23
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Regulation of Software
21 CFR 807Establishment Registration
21 CFR 807Medical Device Listing
21 CFR 807Premarket Notification 510(k)
21 CFR 820Quality System Regulation
21 CFR 801Labeling
21 CFR 803Medical Device Reporting
21 CFR 814Premarket Approval PMA
Basic RegulatoryRequirements
21 CFR 820Quality System Regulation
A - General Provisions
B - Quality SystemRequirements
C – Design Controls
D – Document Controls
E – Purchasing Controls
F – Identificationand Traceability
G – Production & ProcessControls
H – Acceptance Activities
I – Nonconforming Product
J – Corrective & PreventiveAction (CAPA)
K – Labeling & PackagingControl
L – Handling, Storage,Distribution & Installation
M - Records
N - Servicing
O – Statistical Techniques
Quality System Regulation
B - Quality SystemRequirements
820.25(a)General
820.25(b)Training
Quality SystemRequirements
820.22Quality Audit
24
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Basic Requirements
A - General Provisions
B - Quality SystemRequirements
C – Design Controls
D – Document Controls
E – Purchasing Controls
F – Identificationand Traceability
G – Production & ProcessControls
H – Acceptance Activities
I – Nonconforming Product
J – Corrective & PreventiveAction (CAPA)
K – Labeling & PackagingControl
L – Handling, Storage,Distribution & Installation
M - Records
N - Servicing
O – Statistical Techniques
Quality System Regulation
SW Risk/Hazard Analysis
SW Human Factors (Use Errors)
SW Change Control
SW Configuration Management
SW Problem Tracking & Resolution
SW Traceability
Non-Product Software Validation
Design Transfer
Design History File
Training
Software Quality Audits
SW Architecture Verification
SW Detailed Design
SW Detailed Design Verification
SW Coding
SW Code Verification
Unit Test
Integration Test
SW System Test
Beta Testing
SW Verification
SW Validation
COTS Software Components
Procedures
Plans
SW Life-Cycle Model
SW Requirements Analysis
SW Requirements Verification
SW Architectural Design
Corrective & Preventive Action (CAPA)
25
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
26
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Procedures and PlansProcedures
Plans
You must be able to demonstrate that you are“Operating In A State Of Control”
PlansProcedures +
• Establish, in advance of activities, what you are going to do.
• Do what you say you are going to do.• Be able to provide objective (documented) evidence.
27
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Development
SW Architecture Verification
SW Detailed Design
SW Detailed Design Verification
SW Coding
SW Code Verification
SW Life-Cycle Model
SW Requirements Analysis
SW Requirements Verification
SW Architectural Design
28
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
TestingUnit Test
Integration Test
SW System Test
Beta Testing
29
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Verification & ValidationSW Verification
SW Validation
“Engineering Correctness Checks”
“Intended Use Confirmation”
30
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Supporting Processes
SW Risk/Hazard Analysis
SW Human Factors (Use Errors)
SW Change Control
SW Configuration Management
SW Problem Tracking & Resolution
SW Traceability
COTS Software Components
Non-Product Software Validation
Corrective and Preventive Action (CAPA)
31
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
ReleaseDesign Transfer
Design History File
32
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
PersonnelTraining
Software Quality Audits
33
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
34
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
The Reason
WHY we need to have a comprehensive and effective
Software Development Life Cycle
Software Quality and Software Safety
35
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
The Intent Of Regulating Software
Patients
Operators Bystanders ServicePersonnel
Environment
Medical Device Safety and Efficacy
36
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Understanding Defects
Start Development Process Ship
Defects
[2]
37
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Understanding Defects
Start Development Process Ship
Defects
DefectsInjected
[2]
38
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Understanding Defects
Start Development Process Ship
}DefectsShipped
Defects
Defects DetectedAnd Corrected
DefectsInjected
[2]
39
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
A Journey To Fewer DefectsOverall Software Quality
Start Development Process Ship
Defects
InjectFewer
[2]
40
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Quality ModelUnderstanding Defect Injection Rates
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Defect injection rates can be reduced
byPerforming these activities highly effectively
and introducing Causal Analysis
41
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Quality ModelUnderstanding Defect Injection Rates
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Defect injection rates will increase
ifYou do not perform these activities wellor you decide not to do the activity at all
42
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Quality ModelUnderstanding Defect Injection Rates
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Defect Injection Rates are directly related to the completeness and the effectiveness of each
of these activities
43
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Quality ModelUnderstanding Defect Injection Rates
0102030405060708090
100
Sys Reqs
SW Reqs
HL Design
Det Design
Coding
Unit Test
Int Test
SW Sys Test
Sys Valid
Beta Test
Customer
Defects per 1000 lines of code
DefectsInjected
Cum
ulat
ive
Def
ects
44
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
A Journey To Fewer DefectsOverall Software Quality
Start Development Process Ship
DetectEarlier
Detect MoreEffectively
Defects
InjectFewer
[2]
45
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Quality ModelIncreasing Effectiveness
Verification
UnitTest
Verification
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Verification Verification
IntegrationTest
SoftwareSystem
Test
SystemValidation
Beta SiteTesting Customer
46
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
A Journey To Fewer DefectsOverall Software Quality
Start Development Process Ship
} FewerDefects
DetectEarlier
Detect MoreEffectively
Defects
InjectFewer
Zero?
[2]
47
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
48
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelRisk/Hazard Analysis & Use Error Analysis
Verification
UnitTest
Verification
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Verification Verification
IntegrationTest
SoftwareSystem
Test
SystemValidation
Beta SiteTesting Customer
Risk/Hazard AnalysisUse Error Analysis
Harm To:PatientsOperatorsBystandersService PersonnelEnvironment
49
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelRisk/Hazard Analysis & Use Error Analysis
Verification
UnitTest
Verification
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Verification Verification
IntegrationTest
SoftwareSystem
Test
SystemValidation
Beta SiteTesting Customer
Risk/Hazard AnalysisUse Error Analysis
Induced By:Basic FunctionalitySoftware DefectsUse ErrorsEnvironmentInterfaces
50
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Verification
UnitTest
Verification
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Verification Verification
IntegrationTest
SoftwareSystem
Test
SystemValidation
Beta SiteTesting Customer
Software Safety ModelRisk/Hazard Analysis & Use Error Analysis
51
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelRisk/Hazard Analysis & Use Error Analysis
Verification
UnitTest
Verification
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Verification Verification
IntegrationTest
SoftwareSystem
Test
SystemValidation
Beta SiteTesting Customer
Risk/Hazard AnalysisUse Error Analysis
52
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelA Continuous Process Throughout the Life Cycle
Verification
UnitTest
Verification
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Verification Verification
IntegrationTest
SoftwareSystem
Test
SystemValidation
Beta SiteTesting Customer
Risk/Hazard AnalysisUse Error Analysis
53
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelA Continuous Process Throughout the Life Cycle
Verification
UnitTest
Verification
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Verification Verification
IntegrationTest
SoftwareSystem
Test
SystemValidation
Beta SiteTesting Customer
Risk/Hazard AnalysisUse Error Analysis
54
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelA Continuous Process Throughout the Life Cycle
Verification
UnitTest
Verification
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Verification Verification
IntegrationTest
SoftwareSystem
Test
SystemValidation
Beta SiteTesting Customer
Risk/Hazard AnalysisUse Error Analysis
55
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelUse Error Analysis
User Error
Blames The User For Doing Something Wrong
Developer takes accountability for developing softwarethat allowed the user to make an error
User Error –
Use Error –
X
And…..the developer incorporates Use Error Analysisinto the risk management process resulting inthe implementation of built-in safeguards to protect against Use Error
56
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelUse Error Analysis
Use Error (Human Factors) Considerations
Skill Level VariationEnvironmental VariationCompromising FactorsPhysical and Sensory CharacteristicsPerceptionCognitionExpectanciesMental ModelsHome Use
57
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelRisk/Hazard Analysis & Use Error Analysis
Interfaces
Environment
Use Errors
Defects
Basic Functionality
Potential HarmTo
Environment
Potential HarmTo
Service Personnel
Potential HarmTo
Bystanders
Potential HarmTo
Operators
Potential HarmTo
Patients
You are developing afunction where the
user will be asked tomanually enter a
patient’s age
YESYou realize that if the
age is entered incorrectlythat an incorrect diagnosis
might be made
58
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelRisk/Hazard Analysis & Use Error Analysis
PotentialHazard
PotentialEvent Severity Control
Mitigation
PostControlSeverity
V&VFunctionFeature
PatientAge
Entry
IncorrectDiagnosis
Incorrect AgeEntered
(Use Error)
MajorEnter
Date of Birth(cross check)
AcceptableTest
Procedure12345
59
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Safety ModelRisk/Hazard Analysis & Use Error Analysis
60
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
61
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Recall Statistics
FDA Analysis – 3140 Recalls (1992 – 1998)
Software-related recalls – 242Software recalls due to changes – 192 (79%)
“Of those software related recalls, 192 (or 79%) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution”
Software Related Recalls
Due To Changes(79%)
Initial(21%)
FDA Guidance (2002) General Principles of Software Validation
62
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Maintenance Challenges
MaintenanceChallenges
Oversimplification of the taskCustomer and Patient expectationsIncreased requirements on system
ChangesDesign additions and/or modifications
State of the documentationKnowledge level
Personnel changesSoftware components (COTS)
Hardware componentsInterfaces
Cybersecurity issues
63
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Creating A Balance
ChallengesOversimplification of the task
Customer and Patient expectationsIncreased requirements on system
ChangesDesign additions and/or modifications
State of the documentationKnowledge level
Personnel changesSoftware components (COTS)
Hardware componentsInterfaces
Cybersecurity issues
ProcessesRequirements management
Anomaly managementTechnology transition management
Risk managementTraining
Change controlSoftware development life cycle
Technical reviewsValidation planning
TestingConfiguration management
Documentation updates
64
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
65
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Corrective Action – Preventive Action (CAPA)
Problem EncounteredInvestigate
Find Root CauseCorrect The Problem
Same ProductSimilar Problems?
InvestigateFind Root Cause
Correct The Problem
Other ProductsSimilar Problems?
InvestigateFind Root Cause
Correct The Problem
Process ChangePrevent Similar Problems From
Occurring InThe Future
66
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
67
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Quality SystemRegulation
The Regulation• The Quality System Regulation 21 CFR 820
GeneralPrinciples of
Software Validation
SoftwarePre-MarketSubmissionGuidance
Off-The-ShelfSoftwareGuidance
FDA Software Specific References• General Principles of Software Validation• Software Pre-market Submission Guidance• Off-The-Shelf Software Guidance
Medical DeviceQuality
System Manual
Design ControlGuidance
Do It By Design
Guide ToInspections Of
Quality Systems(QSIT)
Medical DeviceUse Safety
Human FactorsRisk Mgmnt
FDA General References• Medical Device Quality System Manual• Design Control Guidance• Do It By Design• Medical Device Use Safety (Human Factors/Use Errors)• Guide To Inspections Of Quality Systems (QSIT)
Industry References• ANSI/AAMI SW68• ISO 62304
ANSI/AAMISW68:2001
SoftwareProcesses
ISO62304
ISO13485
ISO14971 • ISO 13485
• ISO 14971
68
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
GeneralPrinciples of
Software Validation
SoftwarePre-MarketSubmissionGuidance
Off-The-ShelfSoftwareGuidance
FDA Software Specific References• General Principles of Software Validation• Software Pre-market Submission Guidance• Off-The-Shelf Software Guidance
Industry References• ANSI/AAMI SW68• ISO 62304
ANSI/AAMISW68:2001
SoftwareProcesses
ISO62304
69
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
FDA Software-Specific Guidance Documents
70
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
FDA Software-Specific Guidance Documents
71
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
ANSI/AAMI SW68:2001 Medical Device Software - Software life cycle processes
72
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
AAMI TIR32:2004Medical device software risk management
73
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
FDA Website www.fda.gov
Click On“Medical Devices”
74
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
FDA Website CDRH A-Z Index
Click On“CDRH A-Z Index”
75
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
FDA Website
Click On“S” For Software
76
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
FDA Website
Scroll Down To “Software”
77
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
FDA Website
78
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
FDA Websitehttp://www.fda.gov/cdrh/humanfactors/
79
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
AAMI Website www.aami.org
80
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Quality SystemRegulation
Medical DeviceQuality
System Manual
Design ControlGuidance
Do It By Design
Guide ToInspections Of
Quality Systems(QSIT)
Medical DeviceUse Safety
Human FactorsRisk Mgmnt
GeneralPrinciples of
Software Validation
SoftwarePre-MarketSubmissionGuidance
Off-The-ShelfSoftwareGuidance
ANSI/AAMISW68:2001
SoftwareProcesses
SW Risk/Hazard Analysis
SW Human Factors (Use Errors)
SW Change Control
SW Configuration Management
SW Problem Tracking & Resolution
SW Traceability
Non-Product Software Validation
Design Transfer
Design History File
Training
Software Quality Audits
SW Architecture Verification
SW Detailed Design
SW Detailed Design Verification
SW Coding
SW Code Verification
Unit Test
Integration Test
SW System Test
Beta Testing
SW Verification
SW Validation
COTS Software Components
Procedures
Plans
SW Life-Cycle Model
SW Requirements Analysis
SW Requirements Verification
SW Architectural Design
Corrective & Preventive Action (CAPA)
81
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
IntroductionRegulated SoftwareFDA OverviewMedical Device DefinitionSoftware – Special AttentionRegulation Of SoftwareBasic RequirementsSoftware Quality ModelSoftware Safety ModelSoftware MaintenanceCorrective Action and Preventive Action (CAPA)Reference MaterialConclusion
Medical Product Software Development and FDA Regulations
82
Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Software Quality Model
Verification
UnitTest
Verification
SoftwareDetailedDesign
SoftwareCoding
SoftwareHigh-Level
Design
SoftwareRequirements
Verification Verification
IntegrationTest
SoftwareSystem
Test
SystemValidation
Beta SiteTesting Customer
Low Defect Injection Rates
Early and Highly Effective Defect Detection Steps
Risk/Hazard AnalysisUse Error Analysis
CAPA
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Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Patients
Operators Bystanders ServicePersonnel
Environment
It’s All About Making It SafeYour Families! - Your Loved Ones! - Your Friends!
Each and Every One Of YOU!
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Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
Carl R. WyrwaMedicalDeviceSW@aol.comMedicalDeviceSoftware.com
UC Irvine Extension ProgramMedical Product DevelopmentMedical Device Engineering
BME X401Software-Controlled Medical DevicesSoftware Engineering & Compliance
http://unex.uci.edu/certificates/life_sciences/medical_products/details.asp
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Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance
References
[1] – FDA (2002). General Principles of Software Validation; Final Guidance for Industryand FDA Staff. FDA website: http://www.fda.gov/cdrh/comp/guidance/938.pdf
[2] – Pietrasanta, Alfred M. (1990). Defect Prevention. Software Quality Improvement Module 9: Software Engineering Institute, Carnegie Mellon University.
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