CDRH Software Regulation

John F Murray Jr..

Center for Devices & Radiological Health

US Food and Drug Administration

JFM@CDRH.FDA.GOV

Public Health and Software

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

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?

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

0

5

10

15

20

25

30

35

40

45

50

83 84 85 86 87 88 89 90 91 92 93 94 95 96

Year

Num

ber

of R

ecal

lsSOFTWARE RECALLS

1983 - 1996

0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0

Average Number of Software Recalls Per Year

Other

General Hospital

Anesthesiology

Cardiovascular

InVitro Diagnostic

Radiology

1983-91

1992-96

SOFTWARE RECALLSBY DEVICE PANEL

Do the regulations recognize this need

Yes they do:

21 CFR 830.30

21 CFR 830.30 (a) (2) (i)

21 CFR 830.30 (g)

21 CFR 830.70 (i)

21 CFR 820.30 Design Controls

• 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 (a)(2)(i)

• Class I – The following Class I devices are subject to

design controls:• Devices automated with computer software

21 CFR 820.30 (g)

• Design validation shall include software validation and risk analysis where appropriate

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.

What is the goal?

• By Law: Medical Devices must be reasonable safe and effective

• By default: Software must be safe and effective

Safe and Effective

• It depends!

• Cannot be easily defined

• What is safe and effective software– Software Engineering– Risk Management– Quality System

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

a. 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 Problem

1983 1985 1987 1989 1991 1993 1995 1997 1999

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Partial FDA Software Timeline

Part 2RegulatoryOverview

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

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

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