Medical Product Software Development and FDA Regulations

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  • 1. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance IEEE Orange County Computer Society March 27, 2006 Carl R. Wyrwa

2. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA RegulationsIntroduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion2 3. Medical Product Software Development and FDA Regulations Software Development Practices and FDA ComplianceThe Intent Of Regulating SoftwareMedical Device Safety and EfficacyPatients Environment OperatorsBystanders ServicePersonnel 3 4. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Many Stakeholders Keeping A Total Solution In Mind SafetyPatients OperatorsBystanders Service PeopleEnvironmentCustomerMedicalandPractitionersBusinessNeeds All NeedsMetQuality ReviewersSystemsInternal Auditorsand External Reviewers Q&RAPeople DoingTheWork 4 5. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Many Stakeholders Keeping A Balanced Solution In MindSafetyPatients OperatorsBystanders Service People CustomerEnvironmentMedical andPractitioners Business Needs All NeedsMetQuality Systems Reviewers and Internal AuditorsQ&RAExternal ReviewersPeopleDoing The Work 5 6. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA RegulationsIntroduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion6 7. Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance Types of Regulated SoftwareMedical Device Software Software that is actually a part of the medical device itself Software that is an accessory to a medical device Software that itself is a medical device 7 8. Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance Types of Regulated SoftwareMedical Device Software Non-Device Software that is part of: Software that is actually a part The production system of the medical device itself The quality system Software that is an accessorySystems that are used to create to a medical deviceand maintain records required Software that itself is a medicalby FDA regulations device 8 9. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA RegulationsIntroduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion9 10. Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance FDA OverviewFDA 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 dous harmOne of our nation's oldest consumer protection agencies.Located in district and local offices in 157 cities across the country10 11. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Devices 32,35811 12. Medical Product Software Development and FDA Regulations Software Development Practices and FDA ComplianceFDA OverviewAdministrative Enforcement Powers Unannounced and Announced Inspections Inspectional Observations - 483 Warning Letters Adverse Publicity FDA-Initiated Recalls and Monitoring Company-Initiated Recalls Delay, Suspension, or Withdrawal of Product Approvals Preclusion of Government contracts Detention and Refusal of Entry into U.S. Commerce of Imported ProductsJudicial Enforcement Powers Civil Enforcement Powers (Seizure) Criminal Enforcement Powers (Prosecution)12 13. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA RegulationsIntroduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion13 14. Medical Product Software Development and FDA Regulations Software Development Practices and FDA ComplianceMedical Device DefinitionMedical devices range from Simple Devices Tongue depressors and bedpans Complex Devices Programmable pacemakers Laser surgical devices Medical Device Classification Class I, II, and III Class I devices include those with the lowest risk Class III devices includes those with the greatest risk. 14 15. Medical Product Software Development and FDA Regulations Software Development Practices and FDA ComplianceMedical 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."15 16. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA RegulationsIntroduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion16 17. Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance 820.30 Design Control820.30(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 inorder 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 Suction Glove, Surgeons Restraint, Protective System, Applicator, Radionuclide, Manual Source, Radionuclide Teletherapy 17 18. Medical Product Software Development and FDA RegulationsSoftware Development Practices and FDA Compliance Software Special AttentionGeneral Principles of Software Validation 3.3 Software Is Different From Hardware Because of its complexity, the development process for software shouldbe even more tightly controlled than for hardware, in order to preventproblems 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] 18 19. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA RegulationsIntroduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion19 20. Medical Product Software Development and FDA Regulations Software Development Practices and FDA ComplianceRegulation of SoftwareDesign Controls Basic Regulatory Quality System RegulationRequirements 820.30(a) A - General Provisions General B - Quality System21 CFR 807Requirements 820.30(b) Design & Development PlanningEstablishment Registration C Design Controls820.30(c) D Document Controls Design Input21 CFR 807 Medical Device ListingE Purchasing Controls 820.30(d) F IdentificationDesign Output 21 CFR 807 and Traceability G Production & Process820.30(e) Premarket Notification 510(k) ControlsDesign ReviewH Acceptance Activities21 CFR 814820.30(f)Design Verification Premarket Approval PMAI Nonconforming Product J Corrective & Preventive 820.30(g) 21 CFR 820 Action (CAPA) Design Validation K Labeling & Packaging Quality System Regulation Control 820.30(h) L Handling, Storage, Design Transfer 21 CFR 801 Distribution & Installation820.30(i)Labeling M - RecordsDesign ChangesN - Servicing 820.30 (j)21 CFR 803 Design History File20 Medical Device ReportingO Statistical Techniques 21. Medical Product Software Development and FDA Regulations Software Development Practices and FDA ComplianceRegulation of Software Production & Process Controls Basic Regulatory Quality System RegulationRequirements 820.70(a) A - General ProvisionsGeneral B - Quality System21 CFR 807Requirements 820.70(b)Production & Process ChangesEstablishment Registration C Design Controls 820.70(c) D Document Controls21 CFR 807 Environmental ControlMedical Device ListingE Purchasing Controls 820.70(d) F IdentificationPersonnel21 CFR 807 and Traceability G Production & Process820.70(e) Premarket Notification 510(k) ControlsContamination ControlH Acceptance Activities21 CFR 814820.70(f) Buildings Premarket Approval PMAI Nonconforming Product J Corrective & Preventive 820.70(g)21 CFR 820 Action (CAPA) Equipment K Labeling & Packaging Quality System Regulation Control 820.70(h) L Handling, Storage,Manufacturing Material21 CFR 801 Distribution & Installation820.70(i)Labeling M - RecordsAutomated ProcessesN - Servicing21 CFR 80321 Medical Device ReportingO Statistical Techniques 22. Medical Product Software Development and FDA Regulations Software Development Practices and FDA ComplianceRegulation of SoftwareBasic Regulatory Quality System RegulationRequirements A - General Provisions B - Quality System21 CFR 807RequirementsEstablishment Registration C Design ControlsD Document Controls21 CFR 807 Medical Device ListingE Purchasing Controls F Identification21 CFR 807 and Traceability G Production & Process Premarket Notification 510(k) Controls H Acceptance Activities Quality System21 CFR 814 Requirements Premarket Approval PMAI Nonconforming Product J Corrective & Preventive 820.10021 CFR 820 Action (CAPA)Action (CAPA) Corrective & Preventive Action K Labeling & Packaging Quality System RegulationControl L Handling, Storage,21 CFR 801Distribution & InstallationLabeling M - RecordsN - Servicing21 CFR 803 22 Medical Device ReportingO Statistical Techniques 23. Medical Product Software Development and FDA Regulations Software Development Practices and FDA ComplianceRegulation of SoftwareBasic Regulatory Quality System RegulationQuality SystemRequirements Requirements A - General Provisions 820.25(a) B - Quality System General21 CFR 807Requirements 820.25(b)Establishment Registration C Design ControlsTraining D Document Controls21 CFR 807 820.22Quality Audit Medical Device ListingE Purchasing Controls F Identification21 CFR 807 and Traceability G Production & Process Premarket Notification 510(k) Controls H Acceptance Activities21 CFR 814 Premarket Approval PMAI Nonconforming Product J Corrective & Preventive21 CFR 820 Action (CAPA) K Labeling & Packaging Quality System Regulation Control L Handling, Storage,21 CFR 801 Distribution & InstallationLabeling M - RecordsN - Servicing21 CFR 80323 Medical Device ReportingO Statistical Techniques 24. ProceduresMedical Product Software Development and FDA Regulations PlansSoftware Development Practices and FDA ComplianceSW Life-Cycle Model SW Requirements Analysis SW Requirements Verification Software Basic Requirements SW Architectural Design SW Architecture VerificationSW Detailed Design Quality System Regulation SW Detailed Design Verification A - General Provisions SW Coding B - Quality System SW Code Verification RequirementsUnit TestC Design ControlsIntegration TestD Document ControlsSW System Test Beta TestingE Purchasing Controls SW VerificationF Identificationand Traceability SW ValidationG Production & Process COTS Software ComponentsControls SW Risk/Hazard AnalysisH Acceptance Activities SW Human Factors (Use Errors)I Nonconforming ProductSW Change ControlJ Corrective & PreventiveSW Configuration ManagementAction (CAPA)K Labeling & Packaging SW Problem Tracking & ResolutionControlSW TraceabilityL Handling, Storage,Distribution & InstallationNon-Product Software ValidationM - RecordsCorrective & Preventive Action (CAPA) Design TransferN - Servicing Design History File 24O Statistical Techniques Training Software Quality Audits 25. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA RegulationsIntroduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion25 26. Medical Product Software Development and FDA Regulations Software Development Practices and FDA ComplianceProcedures and PlansProcedures Plans You must be able to demonstrate that you areOperating In A State Of Control Procedures+ Plans Establish, in advance of activities, what you are going to do. Do what you say you are going to do.26 Be able to provide objective (documented) evidence. 27. Medical Product Software Development and FDA Regulations Software Development Practices and FDA ComplianceSoftware DevelopmentSW Life-Cycle Model SW Requirements Analysis SW Requirements Verification SW...