Microsoft Word - part820preamblesubpartC design controls.doc

Transcription

1 C. 디자인관리 (Design Controls)(Subpart C) Since early 1984, FDA has identified lack of design controls as one of the major causes of device recalls. The intrinsic quality of devices, including their safety and effectiveness, is established during the design phase. Thus, FDA believes that unless appropriate design controls are observed during preproduction stages of development, a finished device may be neither safe nor effective for its intended use. The SMDA provided FDA with the authority to add preproduction design controls to the device CGMP regulation. Based on its experience with administering the original CGMP regulation, which did not include preproduction design controls, the agency was concerned that the original regulation provided less than an adequate level of assurance that devices would be safe and effective. Therefore, FDA has added general requirements for design controls to the device CGMP regulation for all class III and II devices and certain class I devices. FDA is not subjecting the majority of class I devices to design controls because FDA does not believe that such controls are necessary to ensure that such devices are safe and effective and otherwise in compliance with the act. However, all devices, including class I devices exempt from design controls, must be properly transferred to production in order to comply with Sec , as well as other applicable requirements. For most class I devices, FDA believes that the production and other controls in the new quality system regulation and other general controls of the act will be sufficient, as they have been in the past, to ensure safety and effectiveness. 1984년초반이래로 FDA는의료용구리콜의중요한원인가운데하나가디자인관리의결여에있음을파악했다. 의료용구의안전성및유효성을포함하여, 의료용구의본질적품질은디자인단계에서확립된다. 그러므로생산이전의개발단계에서적절한디자인관리를구축하지않으면, 최종의료용구는목적용도에비추어효과가없거나안전하지않을수있다고확신한다. SMDA는의료용구 CGMP 규정에생산이전단계의디자인관리를추가할권한을 FDA에부여했다. 생산이전단계의디자인관리가없었던최초 CGMP 규정운영경험에근거하여, FDA는최초규정이의료용구의안전성과유효성을적절한수준에서보증하는데부족하다는우려를갖게되었다. 이에따라 FDA는모든클래스 III 및 II 의료용구와일부클래스 I 의료용구에대한의료용구 CGMP 규정에일반적인디자인관리기준을추가했다. 클래스 I 의료용구대다수는디자인관리기준의대상이아니다. 클래스 I 의료용구가안전하고유효함을보증하며법을준수하는데그와같은관리가필요하다고생각하지않기때문이다. 그러나디자인관리에서면제되는클래스 1

2 I 의료용구를포함하여, 모든의료용구는 과기타해당기준준수를위해적절하게생산으로이전되어야한다. 대다수클래스 I 의료용구는, 새로운품질시스템규정에제시된생산및기타관리와법의기타일반관리기준준수면, 지금까지그래왔듯이, 안전성과유효성을보증하는데충분하다고생각된다. 62. Many comments were submitted in response to the addition of design control requirements in general, many questioning how these new requirements would be implemented and enforced. For instance, several comments stated that the design control requirements do not reflect how medical devices are actually developed, because the concept of a design rarely originates with the manufacturer, who may not become involved until relatively late in the design evolution. Others expressed concern that FDA investigators will second-guess design issues in which they are not educated or trained, and stated that investigators should not debate whether medical device designs are "safe and effective." 디자인관리기준의추가와관련하여많은의견이제출되었으며, 이새로운기준의추진및시행방식에대해묻는의견이많았다. 예를들어제조업체는디자인후기단계까지는거의개입하지않으며, 디자인개념이제조업체에서나오는경우는거의없기때문에, 디자인관리기준은의료용구의실제개발과정을반영하고있지않다는의견이많았다. 또한 FDA 실사자가교육이나훈련을받지않은디자인이슈를검토할수있을지우려를표명한사람도있었으며, 의료용구디자인이 " 안전하고효과적 " 인지실사자가평가할수없다는의견도있었다. FDA agrees in part with the comments. The design control requirements are not intended to apply to the development of concepts and feasibility studies. However, once it is decided that a design will be developed, a plan must be established to determine the adequacy of the design requirements and to ensure that the design that will eventually be released to production meets the approved requirements. 이들의견에부분적으로동의한다. 디자인관리기준은개념개발과타당성조사에적용하기위한것은아니다. 하지만일단어떤디자인을개발하기로결정하면, 디자인기준의적절성을결정하고결국에는생산으로이어질그디자인이승인받은기준에부합하도록하기위하여계획을확립해야한다. Those who design medical devices must be aware of the design control requirements in the regulation and comply with them. Unsafe and ineffective 2

3 devices are often the result of informal development that does not ensure the proper establishment and assessment of design requirements which are necessary to develop a medical device that is safe and effective for the intended use of the device and that meets the needs of the user. 의료용구를디자인하는자는이규정의디자인관리기준을숙지하고이를준수해야한다. 안전성과유효성이결여된의료용구는, 사용자의요구에부합하며의료용구의목적용도에비추어안전성과유효성을갖춘의료용구개발에필요한디자인기준을적절하게확립하고평가하지않는비공식적인개발의결과인경우가많다. However, FDA investigators will not inspect a device under the design control requirements to determine whether the design is appropriate or "safe and effective." Section 520(f)(1)(a) of the act precludes FDA from evaluating the "safety or effectiveness of a device" through preproduction design control procedures. FDA investigators will evaluate the process, the methods, and the procedures that a manufacturer has established to implement the requirements for design controls. If, based on any information gained during an inspection, an investigator believes that distributed devices are unsafe or ineffective, the investigator has an obligation to report the observations to the Center for Devices and Radiological Health (CDRH). 그러나 FDA 실사자는디자인관리기준에의거하여그디자인이적절하거나 " 안전하고효과적 " 인지판단하기위한실사를하지않는다. 법섹션 520(f)(1)(a) 는생산이전의디자인관리절차를통해 " 의료용구의안전성또는유효성 " 을 FDA가평가하는부분은배제하고있다. FDA 실사자는제조업체가디자인관리기준이행을위해확립한프로세스, 방법, 그리고절차를평가한다. 실사과정에서확보된정보를근거로유통된의료용구가안전하지않거나유효성이없다고판단되면, 실사자는그관찰사항을 CDRH(Center for Devices and Radiological Health) 에보고할의무가있다. 63. Several comments expressed concern that the application of design controls would severely restrict the creativity and innovation of the design process and suggested that design controls should not apply too early in the design development process. 디자인기준의적용은디자인프로세스의창의성과혁신을심각하게저해할것이라는우려를표하고, 디자인관리를디자인개발프로세스의초기단계에적용해서는안된다고주장한의견이있었다. 3

4 FDA disagrees with the comments. It is not the intent of FDA to interfere with creativity and innovation, and it is not the intent of FDA to apply the design control requirements to the research phase. Instead, the regulation requires the establishment of procedures to ensure that whatever design is ultimately transferred to production is, in fact, a design that will translate into a device that properly performs according to its intended use and user needs. 이들의견에동의하지않는다. 창의성과혁신을저해할의도는없으며, 디자인관리기준을연구단계까지적용할생각도없다. 대신이규정은결국생산으로전환되는디자인은, 실제로목적용도와사용자요구에따라적절하게기능을수행하는의료용구로전환되는디자인을구비하도록하는절차의확립을요구한다. To assist FDA in applying the regulation, manufacturers should document the flow of the design process so that it is clear to the FDA investigator where research is ending and development of the design is beginning. 이규정을적용하는데있어서 FDA를지원하기위하여, 제조업체는디자인프로세스흐름을문서화하여, 연구종료시점과디자인개발시작시점을 FDA 실사자가명확히알수있도록해야한다. 64. A few comments stated that design controls should not be retroactive and that ongoing design development should be exempted. 디자인관리를소급적용해서는안되며지속적인디자인개발은면제해야한다는의견이일부있었다. FDA agrees in part with the comments. FDA did not intend the design requirements to be retroactive, and Sec Design controls will not require the manufacturer to apply such requirements to already distributed devices. When the regulation becomes effective on June 1, 1997, it will apply to designs that are in the design and development phase, and manufacturers will be expected to have the design and development plan established. The manufacturer should identify what stage a design is in for each device and will be expected to comply with the established design and development plan and the applicable paragraphs of Sec from that point forward to completion. If a manufacturer had a design in the development stage before June 1, 1997, and cannot comply with any particular paragraph of Sec , the manufacturer must provide a detailed justification as 4

5 to why such compliance is not possible. However, designs will not have to be recycled through previous phases that have been completed. Manufacturers will be expected to comply in full by June 1, As stated earlier, FDA wants to emphasize that it expects manufacturers to be in a reasonable state of compliance with the design control requirements from June 1, 1997, to June 1, 1998, because extra time was given to the industry for implementing design controls before the final regulation became effective. 이의견에부분적으로동의한다. 디자인기준을소급적용할의도는없으며, " 디자인관리 " 는제조업체가이미유통된의료용구에도이기준을적용하도록요구하지않는다. 이규정이 1997년 6월 1일부터시행되면, 이규정은디자인및개발단계에있는디자인에적용되며, 제조업체는이때부터디자인및개발계획을확립해야할것이다. 제조업체는의료용구별로어디부터디자인단계인지파악해야하며, 그시점부터완성시점까지확립된디자인및개발계획과 의해당조항을준수해야한다. 제조업체가 1997년 6월 1일이전에개발단계에있었던디자인을갖고있으며 의특정조항을준수할수없다면, 그제조업체는그와같은규정준수가가능하지않은이유에대하여상세하게설명해야한다. 그러나이미완료된이전단계를다시거칠필요는없다. 제조업체는 1998년 6월 1일부터이기준을완전히준수해야한다. 앞서설명한바와같이, FDA는 1997년 6월 1일부터 1998년 6월 1일까지디자인관리기준을준수하는합리적인상태에있기를원하며, 이는최종규정이발효되기전에디자인관리를시행할추가시간을업계에주었기때문이다. When changes are made to new or existing designs, the design controls of Sec must be followed to ensure that the changes are appropriate and that the device will continue to perform as intended. FDA notes that the original CGMP regulation contained requirements for specification controls and controls for specification or design changes under Sec (a). 신규또는기존디자인을변경하는경우, 그와같은변경이적절하며해당의료용구가의도한바에따라계속기능을수행하도록하기위하여, 의디자인관리를준수해야한다. 최초 CGMP 규정에도 (a) 에의거한규격관리또는디자인변경기준이포함되어있었다. 65. One comment asked how the proposed design controls would apply to investigational device exemption (IDE) devices, since devices under approved IDE's have been exempt from the CGMP regulation. Some comments suggested that any 5

6 changes to the IDE regulation should be done in a separate rulemaking. Other comments stated that any change to the IDE regulation should be worded so that all of Sec applies since the IDE process is supplying information in support of the design validation requirements but that all design requirements need not be completed prior to the start of the IDE because the clinical evaluation process often brings valuable information to the design project which may need to be incorporated into the design before design transfer. 디자인관리가 IDE(investigational device exemption) 의료용구에도적용되는지묻는의견이있었다. 승인된 IDE 의료용구는 CGMP 규정에서면제되기때문이었다. 또한 IDE 규정의변경은별도로진행해야한다고주장한의견도일부있었다. 이외에도 IDE 프로세스는디자인밸리데이션기준을뒷받침하는정보를제공하기때문에 의모든기준이적용되지만, IDE 시작전까지모든디자인기준이완료될필요는없다는식으로 IDE 규정을변경해야한다는의견이있었다. 임상평가과정에서디자인전환이전에디자인에통합시킬필요가있는중요한정보가확보되기도하기때문이다. The IDE regulation was published in 1976 and last updated in 1978, and has been in effect since that time. Devices being evaluated under IDE's were exempted from the original CGMP regulation because it was believed that it was not reasonable to expect sponsors of clinical investigations to ensure compliance with CGMP's for devices that may never be approved for commercial distribution. However, sponsors of IDE studies were required to ensure that investigational devices were manufactured under a state of control. IDE 규정은 1976년에공표되었으며 1978년에마지막으로개정되었다. 그이후로지금까지시행되고있다. IDE 평가대상의료용구는최초 CGMP 규정에서면제되었다. 상업적유통승인이나지않을수도있는의료용구에대하여임상연구스폰서가 CGMP를모두준수하도록한다는것은합리적이지않다고생각했기때문이다. 그러나 IDE 연구스폰서는연구용의료용구를관리상태에서제조해야한다. With respect to the new regulation, FDA believes that it is reasonable to expect manufacturers who design medical devices to develop the designs in conformance with design control requirements and that adhering to such requirements is necessary to adequately protect the public from potentially harmful devices. The design control requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution. Clinical evaluation is an important aspect of the design verification and validation 6

7 process during the design and development of the device. Because some of the device design occurs during the IDE stage, it is logical that manufacturers who intend to commercially produce the device follow design control procedures. Were a manufacturer to wait until all the IDE studies were complete, it would be too late to take advantage of the design control process, and the manufacturer would not be able to fulfill the requirements of the quality system regulation for that device. 새로운규정과관련하여의료용구를디자인하고이를바탕으로의료용구를개발하는제조업체가디자인관리기준을준수하는것은합리적이며, 그와같은기준준수는유해의료용구로부터일반대중을적절하게보호하는데필요하다고생각한다. 디자인관리기준은디자인대상의료용구가상업적유통을위해생산될때, 의도한바에따라기능을수행하도록하는데필요한기본적인관리대책이다. 임상평가는의료용구디자인및개발과정에서디자인베리피케이션및밸리데이션과정의중요한부분이다. 의료용구디자인중에서일부는 IDE 단계에서발생하므로, 의료용구를상업적으로생산하고자하는제조업체가디자인관리절차를따르는것은합리적이다. 모든 IDE 연구가완료될때까지기다린다면, 디자인관리프로세스에서기대되는바를실현하기에는너무늦을것이며, 제조업체는그의료용구와관련하여품질시스템규정을준수할수없게된다. Therefore, FDA has concurrently amended the IDE regulation, 그러므로 FDA 는 IDE 규정을다음과같이동시에개정했다 적용범위 (Scope to state): (a) * * * An IDE approved under Sec or considered approved under Sec (b) exempts a device from the requirements of the following sections of the Federal Food, Drug, and Cosmetic Act (the act) and regulations issued thereunder: * * * good manufacturing practice requirements under section 520(f) except for the requirements found in Sec , if applicable (unless the sponsor states an intention to comply with these requirements under Sec (b)(3) or Sec (b)(4)(v)) and color additive requirements under section 721. (Emphasis added.) (a) * * * 에의거하여승인된 IDE 또는 812.2(b) 에의거하여승인된것으로간주되는 IDE인경우, 연방식품의약품화장품법 ( 법 ) 다음섹션의기준및그에따라발행된규정 * * * 해당되는경우에 의기준 ( 스폰서가 (b)(3) 또는 (b)(4)(v) 의기준준수의사를언급하지않은경우 ) 및섹션 721의색상첨가물 7

8 기준을제외하고섹션 520(f) 의 GMP 기준의적용으로부터해당의료용구는면제된다. FDA does not expect any new information in IDE applications as a result of this amendment, nor will FDA inspect design controls during bioresearch monitoring inspections. FDA is simply making a conforming amendment to the IDE regulation to make clear that design controls must be followed when design functions are undertaken by manufacturers, including design activity which occurs under an approved IDE. FDA will evaluate the adequacy of manufacturers' compliance with design control requirements in routine CGMP inspections, including preapproval inspections for premarket approval applications (PMA's). 이개정의결과로 IDE 신청서류에새로운정보가요구되지않으며, FDA가바이오연구모니터실사시에디자인관리를실사하지않는다. 단지승인된 IDE에의거하여발생하는디자인활동을포함하여, 제조업체가디자인업무를수행할때디자인관리를준수해야한다는점을명확히하기위하여, IDE 규정을개정한것이다. PMA(premarket approval) 실사를포함하여, CGMP 실사시에제조업체의디자인관리기준준수적절성을평가한다. 66. Many written comments and oral comments at the August and September 1995 meetings recommended that, because design controls are a major addition to the regulation, the effective date for design controls should be delayed until 18 months after publication of the final rule. 디자인관리는이규정에추가되는중요한부분이므로디자인관리의시행일자를최종안공표이후 18개월까지연기해야한다고주장하는의견서가많았으며, 1995년 8월및 9월회의에서도그런의견이많이나왔다. FDA has addressed these comments by extending the effective date of the regulation until June 1, 1997, and by the inspectional strategy described earlier. 이의견을감안하여이규정의시행일자를 1997년 6월 1일까지연장하고앞서설명한실사전략도세웠다. 67. A couple of comments suggested that FDA lacked the authority to establish the design control requirements. 디자인관리기준을확립할권한이 FDA 에게없다는의견도있었다. FDA disagrees with the comments. The act and its legislative history make clear that FDA has the authority to impose those controls necessary to ensure that 8

9 devices are safe and effective. The SMDA gave FDA explicit authority to promulgate design controls, including a process to assess the performance of a device (see section 520(f)(1)(A) of the act). The legislative history of the SMDA supports a "comprehensive device design validation regulation." H. Rept. 808, 101st Cong., 2d sess. 23 (emphasis added). Congress stated that the amendment to the statute was necessary because almost half of all device recalls over a 5-year period were "related to a problem with product design." Id. There is a thorough discussion on the evolution of and need for the design controls in the preamble to the November 23, 1993 (58 FR 61952), proposal. 이의견에동의하지않는다. 법과그의입법과정을보면, FDA는의료용구의안전성과유효성을보증하는데필요한관리기준을부과할권한을갖고있다. SMDA는의료용구의성능평가프로세스를포함하여, 디자인관리를제정할권한을 FDA에게명시적으로부여했다 ( 법섹션 520(f)(1)(A) 참조 ). SMDA의입법과정도 " 포괄적인의료용구디자인밸리데이션규정 " 을뒷받침하고있다. H. Rept. 808, 101st Cong., 2d sess. 23. 또한 5년동안의모든의료용구리콜가운데거의절반은 " 제품디자인문제와관련 " 되어있었기때문에법률개정이필요하다고의회에서도발표했다 ( 상동 ). 1993년 11월 23일자개정안전문 (58 FR 61952) 에서는디자인관리의필요성과배경을자세하게설명하고있다. 68. A few comments objected to FDA requiring design controls for any class I devices in Sec (a) (a) 의클래스 I 의료용구인경우에디자인관리적용을반대한의견이일부있었다. FDA believes that, for the class I devices listed, design controls are necessary and has retained the requirements. Those relatively few devices, while class I, require close control of the design process to ensure that the devices perform as intended, given the serious consequences that could occur if their designs were flawed and the devices were to fail to meet their intended uses. In fact, some of the devices included on the list have experienced failures due to design related problems that have resulted in health hazards, injuries, or death. Further, verification, or even validation, cannot provide the assurance of proper design for some devices, especially those containing extensive software. Thus, all automated devices must be developed under the design control requirements. 목록에거론된클래스 I 의료용구인경우에디자인관리가필요하다고생각하며, 이기준을유지했다. 클래스 I에속하는상대적으로적은의료용구는, 디자인에결함이있고그에 9

10 따라목적용도에부합하지못했을때발생할수있는심각한결과를감안하여, 의료용구가의도한바에따라기능을수행하도록하기위해디자인프로세스의긴밀한관리가요구된다. 사실목록에포함되어있는일부의료용구는디자인관련문제로인하여이상이발생한경우가있었으며, 이에따라위험, 부상, 또는사망이발생하기도했다. 또한베리피케이션또는심지어밸리데이션을실시하더라도, 일부의료용구, 특히광범위한소프트웨어를포함하는의료용구인경우에적절한디자인을보증할수없다. 그러므로모든자동화의료용구는디자인관리기준에의거하여개발해야한다. 69. Several comments stated that FDA has underestimated the complexity of a design project in requiring that the plans identify "persons responsible for each activity" in proposed Sec (b). One comment stated that "define responsibility for implementation" and "activities shall be assigned" were basically redundant requirements. A few other comments stated that ISO 9001:1994 does not call for the design plans to be "approved" and that this requirement should be deleted because it would be burdensome (b) 에서 " 각활동을책임지는자 " 를계획서에명시하도록했는데, 이는 FDA가디자인프로젝트의복잡성을과소평가하고있다는증거라는의견이있었다. " 추진책임규정 " 과 " 활동부여 " 는기본적으로중복되는기준이라는의견도있었다. 이외에도 ISO 9001:1994는디자인계획의 " 승인 " 을요구하지않으며, 이기준은부담이될수있으므로삭제해야한다는의견이있었다. FDA agrees in part with the comments and has revised Sec (b) to require the plan to describe or reference design activities and define responsibility for implementing the activities, rather than requiring that the plan identify each person responsible for carrying out each activity. In making this change, FDA notes that Sec (b)(1) requires manufacturers to establish the appropriate responsibility for activities affecting quality, and emphasizes that the assignment of specific responsibility is important to the success of the design control program and to achieving compliance with the regulation. Also, the design and development activities should be assigned to qualified personnel equipped with adequate resources as required under Sec (b)(2). The requirements under Sec (b) were rewritten to be very similar to the requirements in ISO 9001:1994, sections and FDA does not agree that the design plan should not be "approved." ISO 9001:1994, section requires that the plan be "updated," and section requires that the plan be "regularly reviewed." Therefore, the 10

11 approval is consistent with ISO 9001:1994 and would not be unduly burdensome since the FDA does not dictate how or by whom the plan must be approved. The regulation gives the manufacturer the necessary flexibility to have the same person(s) who is responsible for the review also be responsible for the approval of the plan if appropriate. FDA는이들의견에부분적으로동의하여, 각활동수행을책임지는자가계획서에명시되도록요구하는방식보다는, 계획서에디자인활동을기술하거나참조표시하고활동수행책임을정의하도록요구하는식으로 (b) 를수정했다. 이런식으로수정하는과정에서, (b)(1) 은품질에영향을주는활동에대한적절한책임소재를제조업체가확립하도록요구하고있으며, 구체적인책임할당은디자인관리프로그램의성공과이규정의준수에중요하다고강조하고있음을인식했다. 또한디자인및개발활동은 (b)(2) 에서요구되는바에따라, 적절한자원을구비한적격작업자에게부여해야한다 (b) 의기준은 ISO 9001:1994 섹션 및 4.4.3의기준과유사하도록다시작성했다. 한편디자인계획서를 " 승인 " 받도록해서는안된다는의견에동의하지않는다. ISO 9001:1994 섹션 4.4.2는계획서의 " 업데이트 " 를요구하고있으며, 섹션 4.4.3은계획서의 " 주기적검토 " 를요구하고있다. 그러므로승인은 ISO 9001:1994와일치하며, FDA가계획서의승인방식이나승인주체를지정하고있지않기때문에과도한부담은되지않을것이다. 이규정은검토책임자가적절한경우에는계획서의승인도할수있는유연성을부여하고있다. 70. A few comments stated that the proposed requirement to describe "any interaction between or among different organizational and technical groups" in Sec (b) for the design and development plan should be deleted because it is overly broad, unnecessary, and burdensome. One comment said that the communication expected between these groups should be clarified (b) 의디자인및개발계획에 " 서로다른조직및기술그룹사이의상호작용 " 을기술하도록한기준은너무광범위하고불필요하며과도한부담이되기때문에삭제해야한다는의견이일부있었다. 이들그룹사이에서요구되는커뮤니케이션을명확히해야한다는의견이하나있었다. In response, FDA has amended the requirement as suggested by one comment so that the plan shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design process. Many organization functions, both inside and outside the design group, may contribute to the design 11

12 process. For example, interfaces with marketing, purchasing, regulatory affairs, manufacturing, service groups, or information systems may be necessary during the design development phase. To function effectively, the design plan must establish the roles of these groups in the design process and describe the information that should be received and transmitted. 이들의견을반영하여, 디자인프로세스에투입물을제공하거나투입물을생성하는여러그룹또는활동과의인터페이스를파악하고계획서에기술해야한다는식으로이기준을수정했다. 디자인그룹내부와외부의많은조직기능이디자인프로세스에기여할수있다. 예를들어마케팅, 구매, RA(regulatory affairs), 제조, 서비스그룹, 또는정보시스템과의인터페이스가디자인개발단계에서필요할수있다. 효과적인수행을위해서는, 디자인프로세스에관여하는이들그룹의역할을디자인계획서에명시하고, 받아야할정보와전달해야할정보를기술해야한다. 71. One comment stated that the requirement in Sec (b) that manufacturers establish a design plan completely ignores the creative and dynamic process of designing by requiring a plan to have complete design and testing criteria established, with specifications, before the design process is started. 제조업체가디자인계획서를확립해야한다는 (b) 의기준은, 디자인프로세스를시작하기전에완전한디자인및테스트기준을확립하고규격을설정한계획서를요구함으로써, 디자인의창의적이고역동적인과정을완전히무시하고있다는의견이한건있었다. FDA disagrees with the comment. Section (b) does not require manufacturers to complete design and testing criteria before the design process begins. This section has been revised to state that "plans shall be reviewed, updated, and approved as design and development evolves," indicating that changes to the design plan are expected. A design plan typically includes at least proposed quality practices, assessment methodology, recordkeeping and documentation requirements, and resources, as well as a sequence of events related to a particular design or design category. These may be modified and refined as the design evolves. However, the design process can become a lengthy and costly process if the design activity is not properly defined and planned. The more specifically the activities are defined up front, the less need there will be for changes as the design evolves. 이의견에동의하지않는다. 섹션 (b) 는디자인프로세스를시작하기전에 12

13 제조업체가디자인및테스트기준을완성하도록요구하지않는다. " 디자인및개발과정이진행됨에따라계획서의검토, 업데이트, 승인을실시한다 " 는식으로이섹션을수정하여, 디자인계획의변경이예상된다는점을표현했다. 디자인계획서에는일반적으로예정품질절차, 평가방법, 기록유지및문서화기준, 자원, 그리고특정디자인관련이벤트순서나디자인카테고리가적어도포함된다. 이런부분은디자인이진행되면서변형되고다듬어질수있다. 그러나디자인활동을적절하게정의하고계획하지않으면, 디자인프로세스는길고값비싼것이될수있다. 시작단계에서활동들을보다구체적으로규정하면, 디자인과정에서변경의필요성이줄어들것이다. 72. One comment stated that the language contained in proposed Sec (c) should more closely match that of ISO Many other comments stated that the provision should not require the input requirements to "completely" address the intended use of the device because inputs could never "completely" address the intended use. Several comments stated that the requirement of ISO 9001 that "incomplete, ambiguous or conflicting requirements shall be resolved with those responsible for imposing these requirements" should be added to Sec (c), "Design input," because it is important that the regulation identify the method of resolving conflicting information (c) 의조항은 ISO 9001의것과보다일치시킬필요가있다는의견이한건있었다. 또한디자인투입물은절대목적용도를 " 완벽하게 " 다룰수없으므로, 투입물기준이 " 완벽하게 " 의료용구의목적용도를다루도록해서는안된다는의견이많았다. " 불완전하거나모호하거나대립되는기준은이들기준을부과한자와해결해야한다 " 는 ISO 9001의기준을 (c) " 디자인투입물 " 에추가해야한다는의견이많았다. 대립되는정보의해결방법을제시하는것이중요하기때문이라는이유에서다. FDA agrees with the harmonization comment and has revised the language to incorporate the requirement of section 4.4.4, "Design input," of ISO 9001:1994. FDA does not believe that it is necessary to have identical language to harmonize quality system requirements. ISO 9001:1994, section 4.4.1, "General," requires that the manufacturer "establish and maintain documented procedures to control and verify the design of the product in order to ensure that the specified requirements are met." FDA's regulation, under Sec (a), imposes the same requirements. ISO의기준에맞춰야한다는의견에동의하여, ISO 9001:1994의섹션 " 디자인 13

14 투입물 " 기준을통합하는식으로수정했다. 하지만품질시스템기준의조화를위하여동일한표현을사용할필요는없다고생각한다. ISO 9001:1994 섹션 " 공통 " 은제조업체가 " 지정기준의충족을위하여제품디자인을관리하고확인하는절차문서를확립하고유지 " 할것을요구하고있다 (a) 의 FDA 규정도동일한기준을제시하고있다. Regarding the comments that input requirements cannot completely address the intended use of the device, FDA recognizes that the provision could be interpreted to impose a burden that may not always be possible to meet and has deleted the word "completely." FDA did not intend the provision to suggest that a manufacturer must foresee every possible event. 투입물기준이의료용구의목적용도를완벽하게다룰수없다는의견과관련하여, 항상충족시킬수없는부담을부과하는것으로이조항이해석될수있다는점을인정하며, 그에따라 " 완벽하게 " 라는단어는삭제했다. 제조업체가모든가능한이벤트를예상해야한다는의미는아니다. FDA emphasizes, however, that the section requires the manufacturer to ensure that the design input requirements are appropriate so the device will perform to meet its intended use and the needs of the user. In doing this, the manufacturer must define the performance characteristics, safety and reliability requirements, environmental requirements and limitations, physical characteristics, applicable standards and regulatory requirements, and labeling and packaging requirements, among other things, and refine the design requirements as verification and validation results are established. For example, when designing a device, the manufacturer should conduct appropriate human factors studies, analyses, and tests from the early stages of the design process until that point in development at which the interfaces with the medical professional and the patient are fixed. The human interface includes both the hardware and software characteristics that affect device use, and good design is crucial to logical, straightforward, and safe device operation. The human factors methods used (for instance, task/function analyses, user studies, prototype tests, mock-up reviews, etc.) should ensure that the characteristics of the user population and operating environment are considered. In addition, the compatibility of system components should be assessed. Finally, labeling (e.g., instructions for use) should be tested for usability. 그러나이섹션은제조업체가디자인투입물기준이적절하도록하여, 해당의료용구가 14

15 목적용도와사용자의요구에충족되도록할것을요구하고있다는점을강조하고자한다. 이때제조업체는무엇보다도성능특성, 안전성및신뢰성기준, 환경기준및한계사항, 물리적특성, 적용표준및법적기준, 그리고표시사항및포장기준을규정해야하며, 베리피케이션및밸리데이션결과에근거하여디자인기준을더다듬어야한다. 예를들어의료용구를디자인할때, 제조업체는디자인초기단계부터의료전문가및환자와의인터페이스가확정되는개발시점까지, 적절한사람요소실험, 분석, 테스트를실시해야한다. 사람인터페이스는의료용구사용에영향을주는하드웨어및소프트웨어특성을모두포함하며, 우수한디자인은논리적이고용이하고안전한의료용구작동에매우중요하다. 사람요소방법 ( 예, 과제 / 기능분석, 사용자조사, 프로토타입테스트, 모형검토등 ) 은, 사용자집단및운전환경의특성을고려해야한다. 이외에도시스템컴포넌트의조화성을평가해야한다. 마지막으로, 표시사항 ( 예, 사용설명서 ) 도유용성을테스트해야한다. FDA agrees with the comments, in that it is important that incomplete, ambiguous, or conflicting requirements be resolved with those responsible for imposing these requirements. Therefore, FDA has added the requirement that the procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. FDA notes that this must be done to "ensure that the design requirements are appropriate and address the intended use of the device," as required under Sec (c). 불완전하거나모호하거나대립되는기준은이들기준을제시한자와해결하는것이중요하다는의견에동의한다. 이에따라불완전하거나모호하거나대립되는기준의해결메커니즘을절차에포함시켜야한다는기준을추가했다 (c) 에서요구하는바와같이, " 디자인기준이적절하며의료용구의목적용도를해결할수있도록 " 이작업을진행해야한다. 73. A few other comments stated that ISO 9001:1994 does not call for the design input to be "approved" and therefore, this requirement should be deleted because it would be burdensome. ISO 9001:1994는디자인투입물의 " 승인 " 을요구하지않으므로, 과도한부담이될수있는이기준을삭제해야한다는의견이있었다. FDA does not agree that the "approval" of design input requirements should be deleted, nor that the requirement is inconsistent with ISO. ISO 9001:1994, section 15

16 4.4.4, "Design Input," requires that the design input requirements be "reviewed by the supplier for adequacy." Therefore, the approval would not add any additional burden because FDA does not dictate how or by whom the design input requirements must be approved, thus giving the manufacturer the necessary flexibility to have the same person(s) who is responsible for the "review for adequacy" also be responsible for the approval, if appropriate. Further, it is important that the design input be assessed as early as possible in the development process, making this an ideal time in the device's design development to have a design review to "approve" the design input. 디자인투입물기준의 " 승인 " 을삭제하자거나이기준이 ISO와일치하지않는다는의견에동의하지않는다. ISO 9001:1994 섹션 " 디자인투입물 " 은디자인투입물기준을 " 공급업체가그적절성측면에서검토 " 해야한다고요구하고있다. 그러므로승인은추가적인부담이되지않는다. 디자인투입물기준의승인방법이나주체를 FDA가지정하지않았기때문이다. 그러므로제조업체는적절한경우에 " 적절성검토 " 책임자가승인책임도맡게할수있는유연성을갖는다. 또한디자인투입물을가능하면개발프로세스의초기에평가하는것이중요한데, 이렇게하는것이디자인검토를거쳐디자인투입물을 " 승인 " 하는, 바람직한의료용구디자인개발과정이될수있다. 74. A few comments stated that the proposed requirement under Sec (c) that "design input shall be reviewed and approved by a designated qualified individual" should be deleted as it implies that one person must be designated to review and approve a design, and that there may not be one person who is qualified to assess all of the design input requirements. Addressing the same point, several comments suggested that the provision be revised to allow for more than one person to review and approve the design. One comment said that the FDA's requirement appears to be at odds with the team approach (c) 의 " 디자인투입물을지정된적격자가검토하고승인해야한다 " 는기준은한사람이디자인을검토하고승인하도록지정해야한다는의미이므로삭제해야하며, 모든디자인투입물기준을평가할자격을갖춘사람이없을수도있다는의견이있었다. 이와비슷한차원에서, 한사람이상이디자인을검토하고승인할수있도록수정해야한다는의견이많았다. 또한이기준은팀방식과맞지않는다는의견도있었다. FDA agrees with the concern expressed by the comments and has modified the requirement to allow more than one individual to review and approve the design 16

17 input. FDA endorses the team approach and believes that designs should be reviewed and evaluated by all disciplines necessary to ensure the design input requirements are appropriate. 이들의견에동의하여, 한사람이상이디자인투입물을검토하고승인하도록하는식으로수정했다. FDA는팀방식을인정하며, 디자인투입물기준의적절성보장을위해필요한모든분야의사람들이디자인을검토하고평가해야한다고생각한다. 75. Two comments stated that proposed Sec (c) should be reworded to focus on systems for assuring adequate design input, not on the input itself. One additional comment on this section said that the design input requirements should include not only the device's intended use and needs of the user, but the environmental limits of where it will be used (c) 는투입물자체가아니라적절한디자인결과물을보증하는시스템에중점을두어다시만들어야한다는의견이두건있었다. 또한디자인투입물기준은의료용구의목적용도와사용자의요구사항이외에도, 의료용구가사용될환경조건의제약요소를포함해야한다는의견도한건있었다. FDA agrees that procedures for ensuring appropriate design controls are of the utmost importance and has modified the section to clarify that the manufacturer must establish and maintain procedures to ensure that the design requirements are properly addressed. FDA made this change to the other paragraphs as well, but notes that Sec (a), "General," requires the manufacturer to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. The sections that follow set forth some of the requirements for which procedures must be established. It should be emphasized that the input itself must also be appropriate; the requirement is for the procedures to be defined, documented, and implemented. Thus, if the input requirements related to a device fail to address the intended use of the device, for example, the manufacturer has failed to comply with the provision. 적절한디자인관리를위한절차가매우중요하다는점에동의하며, 제조업체가디자인기준을적절하게다루도록하기위한절차를확립하고유지해야한다는점을명확히하도록수정했다. 다른구절도이와같이수정했지만, (a) " 공통 " 에서지정디자인기준이충족되도록하기위하여의료용구의디자인관리절차를제조업체가확립하고유지해야한다고요구하고있음을지적할필요가있다. 이후의섹션은절차를확립해야한다는 17

18 기준의일부를제시하고있다. 투입물자체가적절해야하며, 이기준은규정 / 문서화 / 시행될절차에대한것임을강조하고자한다. 그러므로의료용구와관련된투입물기준이의료용구의목적용도를제대로다루지못하면, 그제조업체는이조항을준수하지못하는것이된다. FDA also agrees with the additional comment but believes that identifying and establishing the environmental limits for safe and effective device operation is inherent in the requirements for ensuring that a device is appropriate for its intended use. Some factors that must be considered when establishing inputs include, where applicable, a determination of energy (e.g., electrical, heat, and electromagnetic fields), biological effects (e.g., toxicity and biocompatibility) and environmental effects (e.g., electromagnetic interference and electrostatic discharge). 또한추가로제시된의견에동의하지만, 안전하고효과적인의료용구사용의환경적제약요소를파악하고확립해야한다는것은의료용구가목적용도에적절함을보증해야한다는기준에내재되어있다고생각한다. 투입물설정시에고려해야할요소로는, 해당되는경우에에너지 ( 예, 전기, 열, 전자기장 ), 생물학적영향 ( 예, 독성및생물조화성 ), 환경적영향 ( 예, 전자기장애및정전기발생 ) 등이있다. 76. Several comments stated that proposed Sec (f), "Design output," should be rewritten or deleted because many of the requirements were already stated in proposed Secs (d), "Design verification," and (e), "Design review," and, if retained, should be reordered similar to ISO (f) " 디자인결과물 " 의기준은많은부분이이미 (d) " 디자인베리피케이션 " 과 (e) " 디자인검토 " 에명시되어있으므로다시작성하거나삭제하고, 그대로유지한다면 ISO 9001과유사하게순서를조정해야한다는의견이있었다. FDA agrees in part with the comments and has rewritten the requirements of design output to be consistent with ISO 9001:1994, section 4.4.5, "Design output," and reordered the sections to be consistent with ISO 9001:1994. FDA retained the provision, however, because it does not agree that the section is redundant with the sections on design verification, design validation, or design review. Design output are the design specifications which should meet design input requirements, as confirmed during design verification and validation and ensured during design review. The output includes the device, its labeling and packaging, associated 18

19 specifications and drawings, and production and quality assurance specifications and procedures. These documents are the basis for the DMR. The total finished design output consists of the device, its labeling and packaging, and the DMR. 이들의견에부분적으로동의하여, 디자인결과물기준을 ISO 9001:1994 섹션 " 디자인결과물 " 과일치하도록다시작성하고, ISO 9001:1994에맞도록섹션배치를다시조정했다. 하지만이섹션이디자인베리피케이션, 디자인밸리데이션, 또는디자인검토섹션과중복되는것이라는의견에동의하지않으며, 그에따라이조항을그대로두었다. 디자인결과물은디자인투입기준에부합해야하는디자인규격이며, 이는디자인베리피케이션및밸리데이션시에확인하고디자인검토를거쳐보증되어야한다. 결과물은의료용구, 그의표시자재및포장자재, 관련규격및도면, 그리고생산및품질보증규격과절차를포함한다. 이들문서는 DMR의토대가된다. 최종디자인결과물전체는의료용구, 그의표시자재및포장자재, 그리고 DMR로구성된다. 77. One comment stated that the sentence "Design output procedures shall ensure that design output meets the design input requirements" is redundant with the requirement under design verification. Another comment asked what is meant by "release." " 디자인결과물절차는디자인결과물이디자인투입기준에부합하도록해야한다 " 는문장은디자인베리피케이션의기준과중복된다는의견이있었다. 또한 " 배포 " 의의미가무엇인지묻는의견도있었다. FDA agrees with the first comment and has deleted that sentence in Sec (d) but notes that the design output must be documented and expressed in terms that can be verified against the design input requirements. 첫번째의견에동의하여 (d) 에서그문장을삭제했지만, 디자인결과물은디자인투입물기준에대비하여베리피케이션할수있는방식으로표현하고문서화해야한다. Design output can be "released" or transferred to the next design phase at various stages in the design process, as defined in the design and development plan. The design output is reviewed and approved before release or transfer to the next design phase or production. The design output requirements are intended to apply to all such stages of the design process. 디자인결과물은디자인및개발계획에규정되어있는바에따라, 디자인프로세스를구성하는여러단계에서다음단계로 " 배포 " 또는이전될수있다. 다음디자인단계또는 19

20 생산으로배포또는이전되기에앞서, 디자인결과물을검토하고승인한다. 디자인결과물 기준은디자인프로세스가운데그와같은모든단계에적용하기위한것이다. 78. One small manufacturer commented that the problems that Sec (e), "Design review," is meant to reveal involve coordination, cooperation, or communication difficulties among the members of an organization and that these difficulties do not exist in a small company. Therefore, the comment stated that the design review requirements should not apply to small manufacturers (e) " 디자인검토 " 는조직구성원사이의업무조정, 협조, 또는커뮤니케이션어려움때문에나온것이며작은회사에는이런어려움이없다는의견을규모가작은제조업체에서제출했다. 그러므로디자인검토기준을작은제조업체에는적용하지않아도된다고했다. The purpose of conducting design reviews during the design phase is to ensure that the design satisfies the design input requirements for the intended use of the device and the needs of the user. Design review includes the review of design verification data to determine whether the design outputs meet functional and operational requirements, the design is compatible with components and other accessories, the safety requirements are achieved, the reliability and maintenance requirements are met, the labeling and other regulatory requirements are met, and the manufacturing, installation, and servicing requirements are compatible with the design specifications. Design reviews should be conducted at major decision points during the design phase. 디자인단계에서디자인검토를수행하는목적은, 의료용구의목적용도와사용자의요구에비추어디자인이디자인투입기준을충족시키는지확인하기위한것이다. 디자인검토는디자인베리피케이션데이터의검토를포함하는데, 이를통해디자인결과물이기능적 / 운영적기준에부합하는지, 디자인이컴포넌트및기타액세서리와조화를이루는지, 안전기준이달성되었는지, 신뢰성및유지관리기준이충족되는지, 표시사항및기타규제기준이충족되는지, 제조 / 설치 / 서비스기준이디자인규격과조화를이루는지결정한다. 디자인검토는디자인과정중의주요의사결정포인트에서실시해야한다. For a large manufacturer, design review provides an opportunity for all those who may have an impact on the quality of the device to provide input, including manufacturing, quality assurance, purchasing, sales, and servicing divisions. While 20

21 small manufacturers may not have the broad range of disciplines found in a large company, and the need to coordinate and control technical interfaces may be lessened, the principles of design review still apply. The requirements under Sec (e) allow small manufacturers to tailor a design review that is appropriate to their individual needs. 규모가큰제조업체인경우에, 디자인검토는제조, 품질보증, 구매, 세일즈, 서비스부서를포함한, 의료용구의품질에영향을줄수있는모든사람이의견을제시하는기회가된다. 규모가작은업체에는대기업에서발견되는다양한부서가없을수있으며, 업무조정및기술적인터페이스관리필요성이감소될수있지만, 디자인검토의기본원리는그대로적용된다 (e) 의기준은작은업체가자신들의필요에적절하게디자인검토를조정할수있도록허용하고있다. 79. One comment stated that the wording of proposed Sec (e) implies that only one design review is expected, and that design review should be conducted at several stages of product development. Several comments stated that to demand that every design review be conducted by individuals who do not have direct responsibility for design development is impractical, especially for small companies (e) 는단지한번의디자인검토만이기대됨을의미하고있다고지적하며, 디자인검토는제품개발중의여러단계에서실시해야한다는의견이있었다. 디자인개발에직접적인책임을갖지않는자가모든디자인검토를실시하도록요구하는것은실제로가능하지않으며, 특히작은회사가그렇다고지적한의견도다수있었다. FDA agrees with the first comment and has rewritten the requirement to make clear that design reviews must be conducted at appropriate stages of design development, which must be defined in the established design and development plan. The number of design reviews will depend on the plan and the complexity of the device. FDA also amended the requirements so that the results of a design review include identification of the design, the date, and the individual(s) performing the review. Thus, multiple reviews can occur and the manufacturer must document what is being reviewed, when, and by whom. 첫번째의견에동의하여, 디자인검토를디자인개발중에적절한단계별로실시해야하며, 이는디자인및개발계획에규정되어있어야한다는점을명확히하는쪽으로다시작성했다. 디자인검토횟수는의료용구의복잡성과계획에따른다. 또한디자인검토결과에검토를수행한자, 일자, 디자인식별정보가포함되도록수정했다. 그러므로 21

22 검토는여러차례일어날수있으며, 제조업체는검토대상, 검토시점, 검토자를 문서화해야한다. FDA never intended to mandate that an individual without design responsibility conduct the design reviews and, to clarify its position, has rewritten the requirement. The requirement now states that the procedures shall ensure that each design review includes an individual(s) who does not have direct responsibility for the design stage being reviewed. This requirement will provide an "objective view" from someone not working directly on that particular part of the design project, to ensure that the requirements are met. In making this change, FDA also notes that it was not FDA's intention to prohibit those directly responsible for the design from participating in the design review. 디자인책임이없는자가디자인검토를수행해야한다고강제할의도는절대없으며, 이입장을명확히하기위해일부수정했다. 이에따라검토대상디자인단계에직접적인책임을지지않는자가디자인검토에포함되도록하는절차를구비해야한다는식으로했다. 이기준은기준충족을보증하기위하여, 디자인프로젝트가운데특정부분에직접적으로개입해일하지않은자가 " 객관적견해 " 를제공하도록하기위한것이다. 한편디자인을직접적으로책임지는자가디자인검토에참여하지못하게금지하는것이 FDA의의도가아니라는점을강조하고자한다. 80. One comment stated that as part of the systematic review of the adequacy of the device design, it is occasionally necessary to produce a prototype device and have it evaluated by a physician who is an expert in the area of the device's intended use. Thus, the comment stated that the regulation should be revised to allow a means for a manufacturer to ship a prototype device to a physician for evaluation. One comment questioned whether design verification and validation can be conducted using prototypes or machine shop models. 의료용구디자인의적절성을체계적으로검토하기위하여, 프로토타입의료용구를생산하고그의료용구의목적용도영역에서전문가라할수있는의사가평가하게할필요도있다는의견이있었다. 그러므로제조업체가프로토타입의료용구를의사에게보내평가를받는방법도허용하는쪽으로수정해야한다고지적했다. 한편프로토타입이나모델을활용하여디자인베리피케이션과밸리데이션을실시할수있는지문의한의견도있었다. FDA regulations do not prohibit the shipment of prototypes for clinical or other 22

23 studies. Prototypes used in clinical studies involving humans may be shipped in accordance with the IDE provisions in part 812 (21 CFR part 812). 프로토타입을임상시험이나기타연구를위해보내는행위를금지하고있지않다. 사람대상임상연구에사용되는프로토타입은파트 812(21 CFR 파트 812) 의 IDE 조항에의거하여보낼수있다. FDA understands that it is not always practical to conduct clinical studies on finished production units and, therefore, the use of prototypes in clinical studies is acceptable. When prototype devices are used on humans they must be verified as safe to the maximum extent feasible. Final design validation, however, cannot be done on prototypes because the actual devices produced and distributed are seldom the same as the research and development prototypes. The final verification and validation, therefore, must include the testing of actual production devices under actual or simulated use conditions. 최종생산단위에대하여임상시험을실시하는것이항상실제적인것은아니라는점을알고있으며, 그러므로임상시험에프로토타입을활용하는것도가능하다. 프로토타입의료용구를사람에게사용할때는, 그의료용구가안전함을최대한확인해야한다. 그러나최종디자인밸리데이션은프로토타입을상대로실시할수없다. 생산및유통된실제의료용구가연구및개발프로토타입과동일한경우는거의없기때문이다. 그러므로최종베리피케이션및밸리데이션시에는실제또는시뮬레이션사용조건에서실제생산의료용구를대상으로해야한다. 81. A few comments stated that Sec (d), "Design verification," should be rewritten and reordered similar to ISO (d) " 디자인베리피케이션 " 을다시작성하고 ISO 9001과유사하게순서를조정해야한다는의견이일부있었다. FDA agrees with the comments and has rewritten and reordered this section to be consistent with ISO 9001:1994. The language in revised Sec (f) and (g) incorporates the requirement of ISO 9001:1994, sections 4.4.7, "Design verification," and 4.4.8, "Design validation," respectively. 이의견에동의하여 ISO 9001:1994에맞추어이섹션을다시작성하고순서를조정했다. 수정된 (f) 및 (g) 의조항은 ISO 9001:1994 섹션 " 디자인베리피케이션 " 과 " 디자인밸리데이션 " 의기준을통합하고있다. 23

24 Under the revised provisions, the design must be verified and validated. It is important to note that design validation follows successful design verification. Certain aspects of design validation can be accomplished during the design verification, but design verification is not a substitute for design validation. Design validation should be performed under defined operating conditions and on the initial production units, lots, or batches, or their equivalents to ensure proper overall design control and proper design transfer. When equivalent devices are used in the final design validation, the manufacturer must document in detail how the device was manufactured and how the manufacturing is similar to and possibly different from initial production. Where there are differences, the manufacturer must justify why design validation results are valid for the production units, lots, or batches. Manufacturers should not use prototypes developed in the laboratory or machine shop as test units to meet these requirements. Prototypes may differ from the finished production devices. During research and development, conditions for building prototypes are typically better controlled and personnel more knowledgeable about what needs to be done and how to do it than are regular production personnel. When going from laboratory to scale-up production, standards, methods, and procedures may not be properly transferred, or additional manufacturing processes may be added. Often, changes not reflected in the prototype are made in the device to facilitate the manufacturing process, and these may adversely affect device functioning and user interface characteristics. Proper testing of devices that are produced using the same methods and procedures as those to be used in routine production will prevent the distribution and subsequent recall of many unacceptable medical devices. 수정된조항에의하면, 디자인은베리피케이션과밸리데이션이되어야한다. 디자인밸리데이션은성공적인디자인베리피케이션이후에실시한다. 디자인밸리데이션의일부는디자인베리피케이션과정에서달성될수있지만, 디자인베리피케이션은디자인밸리데이션을대체할수없다. 디자인밸리데이션은지정운전조건에서일차생산단위, 로트, 또는배치, 또는이에상응하는것을대상으로실시하여, 전반적으로적절한디자인관리와디자인이전을보장할수있어야한다. 최종디자인밸리데이션에상기의상응하는의료용구를사용한다면, 제조업체는그의료용구의제조방법과일차생산제품과의유사성및차이점을자세하게문서화해야한다. 차이점이있다면, 제조업체는디자인밸리데이션결과가생산단위, 로트, 또는배치에대해서도유효한이유를타당하게설명해야한다. 실험실또는기계공장에서테스트제품으로개발한프로토타입을사용해서는안된다. 24

25 프로토타입은최종생산의료용구와다를수있다. 연구개발시의프로토타입제작조건은일반적으로관리가더잘되고, 정식생산작업자에비하여연구개발사람들은무엇을어떻게할지더잘알고있다. 실험실에서스케일업생산으로전환될때, 표준, 방법, 절차가적절하게이전되지않거나, 제조공정이추가되기도한다. 또한제조공정을원활히하기위하여의료용구가변경되기도하는데, 이런변경은의료용구의기능과사용자인터페이스특성에부정적인영향을줄수있다. 정식생산에서사용되는것과동일한방법과절차에따라생산된의료용구를대상으로적절하게테스트를실시하면, 부적합한의료용구의유통및그에따른리콜을예방할수있다. In addition, finished devices must be tested for performance under actual conditions of use or simulated use conditions in the actual or simulated environment in which the device is expected to be used. The simulated use testing provision no longer requires that the testing be performed on the first three production runs. However, samples must be taken from units, lots, or batches that were produced using the same specifications, production and quality system methods, procedures, and equipment that will be used for routine production. FDA considers this a critical element of the design validation. The requirement to conduct simulated use testing of finished devices is found in the original CGMP in Sec , as part of finished device inspection. This requirement has been moved to Sec (g) because FDA believes that simulated use testing at this point is more effective in ensuring that only safe and effective devices are produced. Manufacturers must also conduct such tests when they make changes in the device design or the manufacturing process that could affect safety or effectiveness as required in the original CGMP in Sec (a)(2). The extent of testing conducted should be governed by the risk(s) the device will present if it fails. FDA considers these activities essential for ensuring that the manufacturing process does not adversely affect the device. 이외에도최종의료용구가사용될것으로예상되는시뮬레이션환경이나실제환경에서, 실제사용조건이나시뮬레이션사용조건에서의성능을테스트해야한다. 시뮬레이션사용테스트조항은, 첫 3개생산작업을대상으로테스트를실시해야한다고더이상요구하지않는다. 그러나일상생산에적용되는것과동일한규격, 생산및품질시스템방법, 절차, 설비를사용하여생산된단위, 로트, 배치에서검체를취해야한다. 디자인밸리데이션의핵심요소가이것이라고 FDA는보고있다. 최종의료용구를대상으로한시뮬레이션사용테스트수행기준은최종의료용구검사의일부로최초 CGMP의 에도있다. 이 25

26 기준은 (g) 로자리를옮겼다. 이시점에서의시뮬레이션사용테스트가안전하고효과적인의료용구만이생산되도록하는데보다효과적이라고믿기때문이다. 또한제조업체는최초 CGMP (a)(2) 에서요구하는바와같이, 안전성또는유효성에영향을줄수있는제조공정또는의료용구디자인을변경할때도그와같은테스트를수행해야한다. 테스트의정도는의료용구에이상이생겼을때발생할리스크수준에의해결정된다. 이러한활동은제조공정이의료용구에부정적인영향을주지않도록하는데필수적인것이라고생각한다. Design validation may also be necessary in earlier stages, prior to product completion, and multiple validations may need to be performed if there are different intended uses. Proper design validation cannot occur without following all the requirements set forth in the design control section of the regulation. 디자인밸리데이션은또한생산완료이전의초기단계에서도필요할수있으며, 목적용도가여럿인경우에는밸리데이션을여러차례실시할필요가있다. 이규정의디자인관리섹션에제시된모든기준을따르지않고는, 적절한디자인밸리데이션이가능할수없다. 82. Several comments stated that adequate controls for verification of design output are contained in proposed Sec (d), "Design verification," and repeated in proposed Sec (f), "Design output." One comment stated that this section will place undue burden on designers and require additional documentation which will add little value to a device's safety and effectiveness. 디자인결과물의베리피케이션관리와관련된사항이 (d) " 디자인베리피케이션 " 에있으면서 (f) " 디자인결과물 " 에도반복되고있다는의견이다수있었다. 이기준은의료용구의안전성과유효성에거의가치를부가하지않는추가적인문서화를요구하며디자이너에게부당한부담을줄수있다는의견도한건있었다. FDA disagrees with the comments. Revised Sec (f), "Design verification," and Sec (g), "Design validation," require verification and validation of the design output. Section (d), "Design output," requires that the output be documented in a fashion that will allow for verification and validation. These sections thus contain different requirements that are basic to establishing that the design output meets the approved design requirements or inputs, including user needs and intended uses. All the requirements are essential to assuring the safety 26

27 and effectiveness of devices. FDA does not believe that these requirements place undue burden on designers or require additional documentation with no value added. These basic requirements are necessary to assure the proper device performance, and, therefore, the production of safe and effective devices, and are acknowledged and accepted as such throughout the world. 이의견에동의하지않는다. 수정된 (f) " 디자인베리피케이션 " 및 (g) " 디자인밸리데이션 " 은디자인결과물의베리피케이션과밸리데이션을요구한다. 섹션 (d) " 디자인결과물 " 은베리피케이션과밸리데이션이가능한방식으로결과물을문서화하도록요구하고있다. 그러므로이들섹션은디자인결과물이사용자요구및목적용도를포함하여승인된디자인기준또는투입물에부합함을확립하는데기본적인, 서로다른기준을제시하는것이다. 이모든기준이의료용구의안전성과유효성을보증하는데필수적이다. 이들기준이아무런가치를부가하지않는추가적인문서화를요구하거나디자이너에게부당한부담을부과한다고생각하지않는다. 기본적인이들기준은적절한의료용구성능보증과안전하고효과적인의료용구의생산을보증하는데필수적이며, 세계적으로도그런것으로인정되고수용되고있다. 83. Several comments stated that the term "hazard analysis" should be defined in reference to design verification. A couple of comments stated that the proposed requirement for design verification, to include software validation and hazard analysis, where applicable, was ambiguous, and may lead an FDA investigator to require software validation and hazard analysis for devices in cases where it is not needed. One comment stated that FDA should provide additional guidance regarding software validation and hazard analysis and what investigators will expect to see. Another comment stated that by explicitly mentioning only software validation and hazard analysis, FDA was missing the opportunity to introduce manufacturers to some powerful and beneficial tools for better device designs and problem avoidance. " 위해요소분석 " 이란용어를디자인베리피케이션과연계하여정의해야한다는의견이있었다. 해당되는경우에소프트웨어밸리데이션과위해요소분석을포함하는디자인베리피케이션기준은애매하며필요하지않은경우에도 FDA 실사자가소프트웨어밸리데이션과위해요소분석을요구하는결과로이어질수있다는의견도있었다. 또한소프트웨어밸리데이션및위해요소분석및실사자의기대사항에관한추가적인가이드라인을제공해야한다는의견도한건있었다. 이외에도소프트웨어밸리데이션과위해요소분석만을명시적으로언급함으로써, 더나은의료용구디자인과문제회피를 27