Center for Devices and Radiological Health
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`DESIGN CONTROL GUIDANCEDESIGN CONTROL GUIDANCE
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`FORFOR
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`MEDICAL DEVICE MANUFACTURERSMEDICAL DEVICE MANUFACTURERS
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`This Guidance relates to
`FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001
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`March 11, 1997
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`Page 1
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`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
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`Medtronic Ex.1771
`Medtronic v. Teleflex
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`FOREWORD
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`To ensure that good quality assurance practices are used for the design of medical devicesand that they are consistent with quality system requirements worldwide, the Food andDrug Administration revised the Current Good Manufacturing Practice (CGMP)requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820.An important component of the revision is the addition of design controls.Because design controls must apply to a wide variety of devices, the regulation does notprescribe the practices that must be used. Instead, it establishes a framework thatmanufacturers must use when developing and implementing design controls. Theframework provides manufacturers with the flexibility needed to develop design controlsthat both comply with the regulation and are most appropriate for their own design anddevelopment processes.This guidance is intended to assist manufacturers in understanding the intent of theregulation. Design controls are based upon quality assurance and engineering principles.This guidance complements the regulation by describing its intent from a technicalperspective using practical terms and examples.Draft guidance was made publicly available in March, 1996. We appreciate the manycomments, suggestions for improvement, and encouragement we received from industry,interested parties, and the Global Harmonization Task Force (GHTF) Study Group 3.The comments were systematically reviewed, and revisions made in response to thosecomments and suggestions are incorporated in this version. As experience is gained withthe guidance, FDA will consider the need for additional revisions within the next six toeighteen months.The Center publishes the results of its work in scientific journals and in its own technicalreports. Through these reports, CDRH also provides assistance to industry and to themedical and healthcare professional communities in complying with the laws andregulations mandated by Congress. These reports are sold by the Government PrintingOffice (GPO) and by the National Technical Information Service (NTIS). Many reports,including this guidance document, are also available via Internet on the World Wide Webat www.fda.gov.We welcome your comments and suggestions for future revisions.D. Bruce Burlington, M.D.DirectorCenter for Devices and Radiological Health
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`PREFACE
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`Effective implementation of design controls requires that the regulation and its intent be wellunderstood. The Office of Compliance within CDRH is using several methods to assistmanufacturers in developing this understanding. Methods include the use of presentations,teleconferences, practice audits, and written guidance.Those persons in medical device companies charged with responsibility for developing,implementing, or applying design controls come from a wide variety of technical and non-technicalbackgrounds––engineering, business administration, life sciences, computer science, and the arts.Therefore, it is important that a tool be provided that conveys the intent of the regulation usingpractical terminology and examples. That is the purpose of his guidance.The response of medical device manufacturers and other interested parties to the March, 1996 draftversion of this guidance has significantly influenced this latest version. Most comments centeredon the complaint that the guidance was too prescriptive. Therefore, it has been rewritten to bemore pragmatic, focusing on principles rather than specific practices.It is noteworthy that many comments offered suggestions for improving the guidance, and that theauthors of the comments often acknowledged the value of design controls and the potential benefitof good guidance to the medical device industry, the public, and the FDA. Some comments evenincluded examples of past experiences with the implementation of controls.Finally, there are several people within CDRH that deserve recognition for their contributions tothe development of this guidance. Al Taylor and Bill Midgette of the Office of Science andTechnology led the development effort and served as co-chairs of the CDRH Design ControlGuidance Team that reviewed the comments received last spring. Team members included AshleyBoulware, Bob Cangelosi, Andrew Lowrey, Deborah Lumbardo, Jack McCracken, GregO'Connell, and Walter Scott. As the lead person within CDRH with responsibility forimplementing the Quality System Regulation, Kim Trautman reviewed the guidance andcoordinated its development with the many other concurrent and related activities. Theircontributions are gratefully acknowledged.FDA would also like to acknowledge the significant contributions made by the GlobalHarmonization Task Force (GHTF) Study Group 3. The Study Group reviewed and revised thisguidance at multiple stages during its development. It is hoped that this cooperative effort will leadto this guidance being accepted as an internationally recognized guidance document through theGHTF later this year.Lillian J. GillDirectorOffice of Compliance
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`ACKNOWLEDGEMENT
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`FDA 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.
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`TABLE OF CONTENTS
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`FOREWORD...................................................................................................................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)............................................................43
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`INTRODUCTION
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`I. PURPOSE
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`This guidance is intended to assist manufacturers in understanding quality systemrequirements concerning design controls. Assistance is provided by interpreting thelanguage of the quality systems requirements and explaining the underlying concepts inpractical terms.Design controls are an interrelated set of practices and procedures that are incorporatedinto the design and development process, i.e., a system of checks and balances. Designcontrols make systematic assessment of the design an integral part of development. As aresult, deficiencies in design input requirements, and discrepancies between the proposeddesigns and requirements, are made evident and corrected earlier in the developmentprocess. Design controls increase the likelihood that the design transferred to productionwill translate into a device that is appropriate for its intended use.In practice, design controls provide managers and designers with improved visibility of thedesign process. With improved visibility, managers are empowered to more effectivelydirect the design process—that is, to recognize problems earlier, make corrections, andadjust resource allocations. Designers benefit both by enhanced understanding of thedegree of conformance of a design to user and patient needs, and by improvedcommunications and coordination among all participants in the process.The medical device industry encompasses a wide range of technologies and applications,ranging from simple hand tools to complex computer-controlled surgical machines, fromimplantable screws to artificial organs, from blood-glucose test strips to diagnosticimaging systems and laboratory test equipment. These devices are manufactured bycompanies varying in size and structure, methods of design and development, and methodsof management. These factors significantly influence how design controls are actuallyapplied. Given this diversity, this guidance does not suggest particular methods ofimplementation, and therefore, must not be used to assess compliance with the qualitysystem requirements. Rather, the intent is to expand upon the distilled language of thequality system requirements with practical explanations and examples of design controlprinciples. Armed with this basic knowledge, manufacturers can and should seek outtechnology-specific guidance on applying design controls to their particular situation.When using this guidance, there could be a tendency to focus only on the time and effortrequired in developing and incorporating the controls into the design process. However,readers should keep in mind the intrinsic value of design controls as well. It is a well-established fact that the cost to correct design errors is lower when errors are detectedearly in the design and development process. Large and small companies that haveachieved quality systems certification under ISO 9001 cite improvements in productivity,product quality, customer satisfaction, and company competitiveness. Additional benefits
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`Introduction 3/11/97Page 1
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`II. SCOPE
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`Quality
`Systems(cid:190)Model for Quality Assurance in Design, Development, Production,
`Installation, and Servicing
`Quality Systems(cid:190)Medical Devices(cid:190)Particular Requirements for the Application of ISO
`9001
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`Introduction 3/11/97Page 2are described in comments received from a quality assurance manager of a medical devicefirm regarding the value of a properly documented design control system:“...there are benefits to an organization and the quality improvement of anorganization by having a written design control system. By defining this system onpaper, a corporation allows all its employees to understand the requirements, theprocess, and expectations of design and how the quality of design is assured andperceived by the system. It also provides a baseline to review the systemperiodically for further improvements based on history, problems, and failures ofthe system (not the product).”
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`The guidance applies to the design of medical devices as well as the design of theassociated manufacturing processes. The guidance is applicable to new designs as well asmodifications or improvements to existing device designs. The guidance discussessubjects in the order in which they appear in FDA's Quality System regulation and is cross-referenced to International Organization for Standards (ISO) 9001:1994,
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`, dated April 1996.Design controls are a component of a comprehensive quality system that covers the life ofa device. The assurance process is a total systems approach that extends from thedevelopment of device requirements through design, production, distribution, use,maintenance, and eventually, obsolescence. Design control begins with development andapproval of design inputs, and includes the design of a device and the associatedmanufacturing processes.Design control does not end with the transfer of a design to production. Design controlapplies to all changes to the device or manufacturing process design, including thoseoccurring long after a device has been introduced to the market. This includesevolutionary changes such as performance enhancements as well as revolutionary changessuch as corrective actions resulting from the analysis of failed product. The changes arepart of a continuous, ongoing effort to design and develop a device that meets the needsof the user and/or patient. Thus, the design control process is revisited many times duringthe life of a product.Some tools and techniques are described in the guidance. Although aspects of their utilityare sometimes described, they are included in the guidance for illustrative purposes only.Including them does not mean that they are preferred. There may be alternative ways thatare better suited to a particular manufacturer and design activity. The literature contains anabundance of information on tools and techniques. Such topics as project management,design review, process capability, and many others referred to in this guidance are
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`, and the ISO draft international standard ISO/DIS 13485,
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`III. APPLICATION OF DESIGN CONTROLS
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`Introduction 3/11/97Page 3available in textbooks, periodicals, and journals. As a manufacturer applies design controlsto a particular task, the appropriate tools and techniques used by competent personnelshould be applied to meet the needs of the unique product or process for thatmanufacturer.
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`Design
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`Design controls may be applied to any product development process. The simple exampleshown in Figure 1 illustrates the influence of design controls on a design process.
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`Figure 1 – Application of Design Controls to Waterfall Design Process (figure used withpermission of Medical Devices Bureau, Health Canada)The development process depicted in the example is a traditional waterfall model. Thedesign proceeds in a logical sequence of phases or stages. Basically, requirements aredeveloped, and a device is designed to meet those requirements. The design is thenevaluated, transferred to production, and the device is manufactured. In practice,feedback paths would be required between each phase of the process and previous phases,representing the iterative nature of product development. However, this detail has beenomitted from the figure to make the influence of the design controls on the design processmore distinct.
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`Introduction 3/11/97Page 4The importance of the design input and verification of design outputs is illustrated by thisexample. When the design input has been reviewed and the design input requirements aredetermined to be acceptable, an iterative process of translating those requirements into adevice design begins. The first step is conversion of the requirements into system or high-level specifications. Thus, these specifications are a design output. Upon verification thatthe high-level specifications conform to the design input requirements, they become thedesign input for the next step in the design process, and so on.This basic technique is used repeatedly throughout the design process. Each design inputis converted into a new design output; each output is verified as conforming to its input;and it then becomes the design input for another step in the design process. In thismanner, the design input requirements are translated into a device design conforming tothose requirements.The importance of design reviews is also illustrated by the example. The design reviewsare conducted at strategic points in the design process. For example, a review isconducted to assure that the design input requirements are adequate before they areconverted into the design specifications. Another is used to assure that the device designis adequate before prototypes are produced for simulated use testing and clinicalevaluation. Another, a validation review, is conducted prior to transfer of the design toproduction. Generally, they are used to provide assurance that an activity or phase hasbeen completed in an acceptable manner, and that the next activity or phase can begin.As the figure illustrates, design validation encompasses verification and extends theassessment to address whether devices produced in accordance with the design actuallysatisfy user needs and intended uses.An analogy to automobile design and development may help to clarify these concepts.Fuel efficiency is a common design requirement. This requirement might be expressed asthe number of miles-per-gallon of a particular grade of gasoline for a specified set ofdriving conditions. As the design of the car proceeds, the requirements, including the onefor fuel efficiency, are converted into the many layers of system and subsystemspecifications needed for design. As these various systems and subsystems are designed,design verification methods are used to establish conformance of each design to its ownspecifications. Because several specifications directly affect fuel efficiency, many of theverification activities help to provide confirmation that the overall design will meet the fuelefficiency requirement. This might include simulated road testing of prototypes or actualroad testing. This is establishing by objective evidence that the design output conforms tothe fuel efficiency requirement. However, these verification activities alone are notsufficient to validate the design. The design may be validated when a representativesample of users have driven production vehicles under a specified range of drivingconditions and judged the fuel efficiency to be adequate. This is providing objectiveevidence that the particular requirement for a specific intended use can be consistentlyfulfilled.
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`CONCURRENT ENGINEERING
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`. Although the waterfall model is a useful tool forintroducing design controls, its usefulness in practice is limited. The model does apply tothe development of some simpler devices. However, for more complex devices, aconcurrent engineering model is more representative of the design processes in use in theindustry. In a traditional waterfall development scenario, the engineering department completes theproduct design and formally transfers the design to production. Subsequently, otherdepartments or organizations develop processes to manufacture and service the product.Historically, there has frequently been a divergence between the intent of the designer andthe reality of the factory floor, resulting in such undesirable outcomes as lowmanufacturing yields, rework or redesign of the product, or unexpectedly high cost toservice the product.One benefit of concurrent engineering is the involvement of production and servicepersonnel throughout the design process, assuring the mutual optimization of thecharacteristics of a device and its related processes. While the primary motivations ofconcurrent engineering are shorter development time and reduced production cost, thepractical result is often improved product quality.Concurrent engineering encompasses a range of practices and techniques. From a designcontrol standpoint, it is sufficient to note that concurrent engineering may blur the linebetween development and production. On the one hand, the concurrent engineeringmodel properly emphasizes that the development of production processes is a designrather than a manufacturing activity. On the other hand, various components of a designmay enter production before the design as a whole has been approved. Thus, concurrentengineering and other more complex models of development usually require acomprehensive matrix of reviews and approvals to ensure that each component andprocess design is validated prior to entering production, and the product as a whole isvalidated prior to design release.
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`RISK MANAGEMENT AND DESIGN CONTROLS
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`. Risk management is thesystematic application of management policies, procedures, and practices to the tasks ofidentifying, analyzing, controlling, and monitoring risk. It is intended to be a frameworkwithin which experience, insight, and judgment are applied to successfully manage risk. Itis included in this guidance because of its effect on the design process.Risk management begins with the development of the design input requirements. As thedesign evolves, new risks may become evident. To systematically identify and, whennecessary, reduce these risks, the risk management process is integrated into the designprocess. In this way, unacceptable risks can be identified and managed earlier in thedesign process when changes are easier to make and less costly.An example of this is an exposure control system for a general purpose x-ray system. Thecontrol function was allocated to software. Late in the development process, risk analysisof the system uncovered several failure modes that could result in overexposure to the
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`THE QUALITY SYSTEM AND DESIGN CONTROLS
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`. In addition to proceduresand work instructions necessary for the implementation of design controls, policies andprocedures may also be needed for other determinants of device quality that should beconsidered during the design process. The need for policies and procedures for thesefactors is dependent upon the types of devices manufactured by a company and the risksassociated with their use. Management with executive responsibility has the responsibilityfor determining what is needed.Example of topics for which policies and procedures may be appropriate are:
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`Introduction 3/11/97Page 6patient. Because the problem was not identified until the design was near completion, anexpensive, independent, back-up timer had to be added to monitor exposure times.
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`risk management
`device reliability
`device durability
`device maintainability
`device serviceability
`human factors engineering
`software engineering
`use of standards
`configuration management
`compliance with regulatory requirements
`device evaluation (which may include third party product certification or approval)
`clinical evaluations
`document controls
`use of consultants
`use of subcontractors
`use of company historical data
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`SECTION A. GENERAL
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`I. REQUIREMENTS
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`§ 820.30(a) General
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`.(1)Each manufacturer of any class III or class II device, and the class I devices listedin paragraph (a) (2) of this section, shall establish and maintain procedures tocontrol the design of the device in order to ensure that specified designrequirements are met.(2)The following class I devices are subject to design controls:(i)Devices automated with computer software; and(ii)The devices listed in the chart below.SectionDevice868.6810Catheter, Tracheobronchial Suction878.4460Glove, Surgeon’s880.6760Restraint, Protective892.5650System, Applicator, Radionuclide,Manual892.5740Source, Radionuclide Teletherapy
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`II. DEFINITIONS
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`§ 820.3 (n) Management with executive responsibility
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` means those senior employees of amanufacturer who have the authority to establish or make changes to the manufacturer’squality policy and quality system.
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`§ 820.3 (s) Quality
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`Quality system
`§ 820.3 (v)
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`Cross reference to ISO 9001:1994 and ISO/DIS 13485 Section 4.4.1 General.
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`III. DISCUSSION AND POINTS TO CONSIDER
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`The essential quality aspects and the regulatory requirements, such as safety, performance,and dependability of a product (whether hardware, software, services, or processedmaterials) are established during the design and development phase. Deficient design canbe a major cause of quality problems.The context within which product design is to be carried out should be set by themanufacturer’s senior management. It is their responsibility to establish a design anddevelopment plan which sets the targets to be met. This plan defines the constraintswithin which the design is to be implemented.The quality system requirements do not dictate the types of design process that amanufacturer must use. Manufacturers should use processes best suited to their needs.However, whatever the processes may be, it is important that the design controls areapplied in an appropriate manner. This guidance document contains examples of how thismight be achieved in a variety of situations.It is important to note that the design function may apply to various facets of the operationhaving differing styles and time scales. Such facets are related to products, includingservices and software, as well as to their manufacturing processes.Senior management needs to decide how the design function is to be managed and bywhom. Senior management should also ensure that internal policies are established fordesign issues such as:
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`patenting or other means of design protectionIt is for senior management to ensure that adequate resources are available to carry outthe design in the required time. This may involve reinforcing the skills and equipmentavailable internally and/or obtaining external resources.
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`assessing new product ideas
`training and retraining of design managers and design staff
`use of consultants
`evaluation of the design process
`product evaluation, including third party product certification and approvals
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`SECTION B. DESIGN AND DEVELOPMENT PLANNING
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`I. REQUIREMENTS
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`§ 820.30(b) Design and development planning.
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`Each manufacturer shall establish and maintain plans that describe or reference thedesign and development activities and define responsibility for implementation.
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`The plans shall identify and describe the interfaces with different groups oractivities that provide, or result in, input to the design and development process.
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`The plans shall be reviewed, updated, and approved as design and developmentevolves.
`Cross-reference to ISO 9001:1994 and ISO/DIS 13485 sections 4.4.2 Design and
`development planning and 4.4.3 Organizational and technical interfaces.
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`II. DISCUSSION AND POINTS TO CONSIDER
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`Design and development planning is needed to ensure that the design process isappropriately controlled and that device quality objectives are met. The plans must beconsistent with the remainder of the design control requirements. The following elementswould typically be addressed in the design and development plan or plans:
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`Description of the goals and objectives of the design and development program;i.e., what is to be developed;
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`Delineation of organizational responsibilities with respect to assuring qualityduring the design and development phase, to include interface with anycontractors;
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`Identification of the major tasks to be undertaken, deliverables for each task, andindividual or organizational responsibilities (staff and resources) for completingeach task;
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`Selection of reviewers, the composition of review teams, and procedures to befollowed by reviewers;
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`Notification activities.Planning enables management to exercise greater control over the design and developmentprocess by clearly communicating policies, procedures, and goals to members of the
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`Scheduling of major tasks to meet overall program time constraints;
`Identification of major reviews and decision points;
`Controls for design documentation;
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`. The management responsibility section ofthe quality system requirements1 requires management to establish a quality policy andimplement an organizational structure to ensure quality. These are typically documented ina quality manual or similarly named document. In some cases, however, the design anddevelopment plan, rather than the quality manual, is the best vehicle for describingorganizational responsibilities relative to design and development activities. Theimportance of defining responsibilities with clarity and without ambiguity should berecognized. When input to the design is from a variety of sources, their interrelationshipsand interfaces (as well as the pertinent responsibilities and authorities) should be defined,documented, coordinated, and controlled. This might be the case, for example, if amultidisciplinary product development team is assembled for a specific project, or if theteam includes suppliers, contract manufacturers, users, outside consultants, or independentauditors.
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`Section B Design and Development Planning 3/11/97Page 10design and development team, and providing a basis for measuring conformance to qualitysystem objectives.Design activities should be specified at the level of detail necessary for carrying out thedesign process. The extent of design and development planning is dependent on the sizeof the developing organization and the size and complexity of the product to bedeveloped. Some manufacturers may have documented policies and procedures whichapply to all design and development activities. For each specific development program,such manufacturers may also prepare a plan which spells out the project-dependentelements in detail, and incorporates the general policies and procedures by reference.Other manufacturers may develop a comprehensive design and development plan which isspecifically tailored to each individual project.In summary, the form and organization of the planning documents are less important thantheir content. The following paragraphs discuss the key elements of design anddevelopment planning.
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`The prerequisite information necessary to start each major task and theinterrelationship between tasks
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`Constraints, such as applicable codes, standards, and regulations 1 § 820.20 of the FDA Quality System Regulation; section 4.1 of ISO 9001 and ISO/DIS 13485.
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`ORGANIZATIONAL RESPONSIBILITIES
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`TASK BREAKDOWN
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`. The plan establishes, to the extent possible:
`The major tasks required to develop the product
`The time involved for each major task
`The resources and personnel required
`The allocation of responsibilities for completing each major task
`The form of each task output or deliverable
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`Section B Design and Development Planning 3/11/97Page 11Tasks for all significant design activities, including verification and validation tasks, shouldbe included in the design and development plan. For example, if clinical trials areanticipated, there may be tasks associated with appropriate regulatory requirements.For complex projects, rough estimates may be provided initially, with the details left forthe responsible organizations to develop. As development proceeds, the plan shouldevolve to incorporate mo