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CDRH Software Regulation

CDRH Software Regulation

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CDRH Software Regulation

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  1. CDRH Software Regulation John F Murray Jr.. Center for Devices & Radiological Health US Food and Drug Administration JFM@CDRH.FDA.GOV

  2. The Quality of Pubic Health is highly dependent on the Quality of Medical Software i.e. Medical Device Software, Clinical Information Systems, Hospital Information Systems, Manufacturing Systems etc Public Health and Software

  3. 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? What type of Quality do we Want?

  4. SOFTWARE IS DIFFERENT • Software Quality - Primarily a design issue • Custom developed components • Complexity • Structured development process plus testing • Dormant latent defects • Software is easy to change • Difficult to control changes • Significance of changes

  5. SOFTWARE RECALLS1983 - 1996


  7. Yes they do: 21 CFR 830.30 21 CFR 830.30 (a) (2) (i) 21 CFR 830.30 (g) 21 CFR 830.70 (i) Do the regulations recognize this need

  8. Each 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. 21 CFR 820.30 Design Controls

  9. Class I The following Class I devices are subject to design controls: Devices automated with computer software 21 CFR 820.30 (a)(2)(i)

  10. Design validation shall include software validation and risk analysis where appropriate 21 CFR 820.30 (g)

  11. 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. 21 CFR 820.70 (i)

  12. What is the goal? • By Law: Medical Devices must be reasonable safe and effective • By default: Software must be safe and effective

  13. Safe and Effective • It depends! • Cannot be easily defined • What is safe and effective software • Software Engineering • Risk Management • Quality System

  14. CDRH Software Message • The law and regulations are written in broad terms • Software should be engineered using: • Software Engineering • Risk Management • Quality System This is the CDRH Software Message

  15. 1983 1985 1987 1989 1991 1993 1995 1997 1999 a c d e f g h j l p q t b i k m r u n s v o a. Guide to Computerized Systems in Drug Processing b. Software Development Activities Reference Materials and Training Aids for Investigators c. Draft FDA Policy for the Regulation of Computer Products d. 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 Devices f. Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review g. Draft Guideline for the Validation of Blood Establishment Computer Systems (Version 1 issued Oct-94) h. Letter requiring submissions for Blood Bank Information Systems i. Proposed Electronic Records: Electronic Signatures Rule j. Glossary of Computerized System and Software Development Terminology k. CADx Initiative l. Telemedicine Related Activities Report m. Public FDA Software Policy Workshop n. Public Draft ODE Guidance for the Content of Premarket Submission for Medical Devices Containing Software o. New Quality System Regulation p. Do It By Design q. Blood Bank Software Submission Guidance r. Software Quality Audit Initiative s. Final Rule Electronic Records: Electronic Signatures t. General Principles of Software Validation - Draft Guidance u. Guidance for Off-the-Shelf (OTS) Software Use in Medical Devices - Draft v. Letter to Manufacturers Regarding the Year 2000 Computer Problem Part 2 Regulatory Overview Partial FDA Software Timeline

  16. Documents to date General 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 Management • AAMI TIR on Validation of High Risk Software • AAMI TIR on Validation of Quality System and Manufacturing Software

  18. We have been at this a long time • Our first publication was 1991 • We continue to support standards development • We continue to support the development of TIR • Training to come