Design Control Guidance - Food and Drug Administration
Design Control Guidance - Food and Drug Administration Design Control Guidance - Food and Drug Administration
more likely to be made with appropriate oversight and consideration of all relevant factors.Thus, when concessions to the clock must be made, they can be justified and supported.Section B Design and Development Planning 3/11/97 Page 12
SECTION C. DESIGN INPUTI. REQUIREMENTS§ 820.30(c) Design input.• Each manufacturer shall establish and maintain procedures to ensure that thedesign requirements relating to a device are appropriate and address the intendeduse of the device, including the needs of the user and patient.• The procedures shall include a mechanism for addressing incomplete, ambiguous,or conflicting requirements.• The design input requirements shall be documented and shall be reviewed andapproved by designated individual(s).• The approval, including the date and signature of the individual(s) approving therequirements, shall be documented.Cross reference to ISO 9001:1994 and ISO/DIS 13485 section 4.4.4 Design input.II. DEFINITIONS§ 820.3(f) Design input means the physical and performance requirements of a devicethat are used as a basis for device design.III. DISCUSSION AND POINTS TO CONSIDERDesign input is the starting point for product design. The requirements which form thedesign input establish a basis for performing subsequent design tasks and validating thedesign. Therefore, development of a solid foundation of requirements is the single mostimportant design control activity.Many medical device manufacturers have experience with the adverse effects thatincomplete requirements can have on the design process. A frequent complaint ofdevelopers is that “there’s never time to do it right, but there’s always time to do it over.”If essential requirements are not identified until validation, expensive redesign and reworkmay be necessary before a design can be released to production.By comparison, the experience of companies that have designed devices using clear-cut,comprehensive sets of requirements is that rework and redesign are significantly reducedand product quality is improved. They know that the development of requirements for amedical device of even moderate complexity is a formidable, time-consuming task. Theyaccept the investment in time and resources required to develop the requirements becausethey know the advantages to be gained in the long run.Section C. Design Input 3/11/97 Page 13
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- Page 10 and 11: are described in comments received
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- Page 32 and 33: capabilities. The external focus is
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- Page 38 and 39: manufacturers are encouraged to use
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SECTION C. DESIGN INPUTI. REQUIREMENTS§ 820.30(c) <strong>Design</strong> input.• Each manufacturer shall establish <strong>and</strong> maintain procedures to ensure that thedesign requirements relating to a device are appropriate <strong>and</strong> address the intendeduse of the device, including the needs of the user <strong>and</strong> patient.• The procedures shall include a mechanism for addressing incomplete, ambiguous,or conflicting requirements.• The design input requirements shall be documented <strong>and</strong> shall be reviewed <strong>and</strong>approved by designated individual(s).• The approval, including the date <strong>and</strong> signature of the individual(s) approving therequirements, shall be documented.Cross reference to ISO 9001:1994 <strong>and</strong> ISO/DIS 13485 section 4.4.4 <strong>Design</strong> input.II. DEFINITIONS§ 820.3(f) <strong>Design</strong> input means the physical <strong>and</strong> performance requirements of a devicethat are used as a basis for device design.III. DISCUSSION AND POINTS TO CONSIDER<strong>Design</strong> input is the starting point for product design. The requirements which form thedesign input establish a basis for performing subsequent design tasks <strong>and</strong> validating thedesign. Therefore, development of a solid foundation of requirements is the single mostimportant design control activity.Many medical device manufacturers have experience with the adverse effects thatincomplete requirements can have on the design process. A frequent complaint ofdevelopers is that “there’s never time to do it right, but there’s always time to do it over.”If essential requirements are not identified until validation, expensive redesign <strong>and</strong> reworkmay be necessary before a design can be released to production.By comparison, the experience of companies that have designed devices using clear-cut,comprehensive sets of requirements is that rework <strong>and</strong> redesign are significantly reduced<strong>and</strong> product quality is improved. They know that the development of requirements for amedical device of even moderate complexity is a formidable, time-consuming task. Theyaccept the investment in time <strong>and</strong> resources required to develop the requirements becausethey know the advantages to be gained in the long run.Section C. <strong>Design</strong> Input 3/11/97 Page 13
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