Presentation on theme: "CDRH Software Regulation"— Presentation transcript:
1 CDRH Software Regulation John F Murray Jr..Center for Devices & Radiological HealthUS Food and Drug Administration
2 Public Health and Software The Quality of Pubic Health is highly dependent on the Quality of Medical Softwarei.e. Medical Device Software, Clinical Information Systems, Hospital Information Systems, Manufacturing Systems etc
3 What type of Quality do we Want? To get some perspective lets try what I call the YB scale. [yugo vs. bmw]I ask the following questions:Where would Microsoft be on this scale?Where do we want our software quality to be?
4 SOFTWARE IS DIFFERENT Software Quality - Primarily a design issue Custom developed componentsComplexityStructured development process plus testingDormant latent defectsSoftware is easy to changeDifficult to control changesSignificance of changesTesting alone is not sufficient to show that software implementation is correct and complete. Need a structured and controlled development process that includes testing as one component.
7 Do the regulations recognize this need Yes they do:21 CFR21 CFR (a) (2) (i)21 CFR (g)21 CFR (i)
8 21 CFR Design ControlsEach manufacturer of any Class II or Class III 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 the specified design requirements are meet.
9 21 CFR (a)(2)(i)Class IThe following Class I devices are subject to design controls:Devices automated with computer software
10 21 CFR (g)Design validation shall include software validation and risk analysis where appropriate
11 21 CFR 820.70 (i) Automated processes When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities shall be documented.
12 What is the goal?By Law: Medical Devices must be reasonable safe and effectiveBy default: Software must be safe and effective
13 Safe and Effective It depends! Cannot be easily defined What is safe and effective softwareSoftware EngineeringRisk ManagementQuality System
14 CDRH Software Message This is the CDRH Software Message The law and regulations are written in broad termsSoftware should be engineered using:Software EngineeringRisk ManagementQuality SystemThis is the CDRH Software Message
15 Partial FDA Software Timeline RegulatoryOverviewPartial FDA Software Timeline1999aedcbijhqfgmonlrpkstvua. Guide to Computerized Systems in Drug Processingb. Software Development Activities Reference Materials and Training Aids for Investigatorsc. Draft FDA Policy for the Regulation of Computer Productsd. Draft Application of the Medical Device GMPs to Computerized Devices and Manufacturing Processes (Final 1992)e. Draft Guidance for the Content and Review of 510(k) Notifications for Picture Archiving and Communications Systems(PACS)and Related Devicesf. Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Reviewg. Draft Guideline for the Validation of Blood Establishment Computer Systems (Version 1 issued Oct-94)h. Letter requiring submissions for Blood Bank Information Systemsi. Proposed Electronic Records: Electronic Signatures Rulej. Glossary of Computerized System and Software Development Terminologyk. CADx Initiativel. Telemedicine Related Activities Reportm. Public FDA Software Policy Workshopn. Public Draft ODE Guidance for the Content of Premarket Submission for Medical Devices Containing Softwareo. New Quality System Regulationp. Do It By Designq. Blood Bank Software Submission Guidancer. Software Quality Audit Initiatives. Final Rule Electronic Records: Electronic Signaturest. General Principles of Software Validation - Draft Guidanceu. Guidance for Off-the-Shelf (OTS) Software Use in Medical Devices - Draftv. Letter to Manufacturers Regarding the Year 2000 Computer ProblemNew draft of submission guidance to be reissued for industry comment Dec. or Jan.FDA initiative via AAMI for new international software standard for medical device software.Revision of ISO in process and very different.
16 Documents to dateGeneral Principles of Software Validation; Final Guidance for Industry and FDA Staff OC Guidance for Off-the-Shelf Software Use in Medical Devices; Final ODE Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Final
17 Other Works AAMI SW 68 IEC/ISO International Version of SW 68 AAMI TIR on Software Hazard ManagementAAMI TIR on Validation of High Risk SoftwareAAMI TIR on Validation of Quality System and Manufacturing Software
18 We have been at this a long time Our first publication was 1991We continue to support standards developmentWe continue to support the development of TIRTraining to come