Design Control Guidance - Food and Drug Administration
Design Control Guidance - Food and Drug Administration Design Control Guidance - Food and Drug Administration
ACKNOWLEDGEMENTFDA wishes to acknowledge the contributions of the Global Harmonization Task Force(GHTF) Study Group 3 to the development of this guidance. As has been stated in thepast, FDA is firmly committed to the international harmonization of standards andregulations governing medical devices. The GHTF was formed in 1992 to further thiseffort. The GHTF includes representatives of the Canadian Ministry of Health andWelfare; the Japanese Ministry of Health and Welfare; FDA; industry members from theEuropean Union, Australia, Canada, Japan, and the United States; and a few delegatesfrom observing countries.Among other efforts, the GHTF Study Group 3 started developing guidance on theapplication of design controls to medical devices in the spring of 1995. Study Group 3has recognized FDA’s need to publish timely guidance on this topic in conjunction withpromulgation of its new Quality System Regulation. The Study Group has thereforedevoted considerable time and effort to combine its draft document with the FDA's effortsas well as to review and comment on FDA's subsequent revisions. FDA, for its part,delayed final release of its guidance pending final review by the Study Group. As a result,it is hoped that this document, with some minor editorial revisions to make the guidanceglobal to several regulatory schemes, will be recognized through the GHTF as aninternational guidance document.iv
TABLE OF CONTENTSFOREWORD ................................................................................................................... iPREFACE...................................................................................................................... iiiACKNOWLEDGEMENT.............................................................................................. ivTABLE OF CONTENTS ................................................................................................ vINTRODUCTION .......................................................................................................... 1SECTION A. GENERAL............................................................................................... 7SECTION B. DESIGN AND DEVELOPMENT PLANNING ........................................ 9SECTION C. DESIGN INPUT .................................................................................... 13SECTION D. DESIGN OUTPUT................................................................................ 19SECTION E. DESIGN REVIEW................................................................................. 23SECTION F. DESIGN VERIFICATION ..................................................................... 29SECTION G. DESIGN VALIDATION ....................................................................... 33SECTION H. DESIGN TRANSFER............................................................................ 37SECTION I. DESIGN CHANGES............................................................................... 39SECTION J. DESIGN HISTORY FILE (DHF)............................................................ 43v
- Page 1: Center for Devices and Radiological
- Page 5: PREFACEEffective implementation of
- Page 10 and 11: are described in comments received
- Page 12 and 13: The importance of the design input
- Page 14 and 15: patient. Because the problem was no
- Page 16 and 17: III. DISCUSSION AND POINTS TO CONSI
- Page 18 and 19: design and development team, and pr
- Page 20 and 21: more likely to be made with appropr
- Page 22 and 23: Unfortunately, there are a number o
- Page 24 and 25: SCOPE AND LEVEL OF DETAIL. Design i
- Page 26 and 27: • The environment in which the pr
- Page 28 and 29: the design and development plan, an
- Page 30 and 31: Section D. Design Output 3/11/97 Pa
- Page 32 and 33: capabilities. The external focus is
- Page 34 and 35: Qualifications. Formal design revie
- Page 36 and 37: action. In other cases, the reviewe
- Page 38 and 39: manufacturers are encouraged to use
- Page 40 and 41: Another self-documenting verificati
- Page 42 and 43: III. DISCUSSION AND POINTS TO CONSI
- Page 44 and 45: Section G. Design Validation 3/11/9
- Page 46 and 47: Historically, shortcomings in the p
- Page 48 and 49: DOCUMENT CONTROL. The features of a
- Page 50 and 51: Section I. Design Changes 3/11/97 P
- Page 52 and 53: software in each machine. The contr
ACKNOWLEDGEMENTFDA wishes to acknowledge the contributions of the Global Harmonization Task Force(GHTF) Study Group 3 to the development of this guidance. As has been stated in thepast, FDA is firmly committed to the international harmonization of st<strong>and</strong>ards <strong>and</strong>regulations governing medical devices. The GHTF was formed in 1992 to further thiseffort. The GHTF includes representatives of the Canadian Ministry of Health <strong>and</strong>Welfare; the Japanese Ministry of Health <strong>and</strong> Welfare; FDA; industry members from theEuropean Union, Australia, Canada, Japan, <strong>and</strong> the United States; <strong>and</strong> a few delegatesfrom observing countries.Among other efforts, the GHTF Study Group 3 started developing guidance on theapplication of design controls to medical devices in the spring of 1995. Study Group 3has recognized FDA’s need to publish timely guidance on this topic in conjunction withpromulgation of its new Quality System Regulation. The Study Group has thereforedevoted considerable time <strong>and</strong> effort to combine its draft document with the FDA's effortsas well as to review <strong>and</strong> comment on FDA's subsequent revisions. FDA, for its part,delayed final release of its guidance pending final review by the Study Group. As a result,it is hoped that this document, with some minor editorial revisions to make the guidanceglobal to several regulatory schemes, will be recognized through the GHTF as aninternational guidance document.iv
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