On March 20, 1998, the Center for Devicesand Radiological Health (CDRH) announced the availability of a guidancedocument entitled, "The New 510(k) Paradigm -- Alternatives to DemonstratingSubstantial Equivalence in Premarket Notification Submissions. " In thisguidance, two new alternatives to the traditional approach of demonstratingsubstantial equivalence were discussed. Both alternatives, i. e. , the Special510(k) and the Abbreviated 510(k), were designed toprovide flexibility to the device industry, conserve Agency and industryresources, and optimize the contribution of the 510(k) Program to theprotection of public health.
1998年3月20日，器械和放射卫生中心（CDRH）宣布提供一份指导文件，“新的510（k）范式 - 在上市前通知提交中证明实质等效性的替代方案”。在本指导中，讨论了传统方法展示实质等效性的两种新方法。两种选择，即特殊510（k）和缩简510（k），旨在为器械行业提供灵活性，节约机构和行业资源，并优化510（k）计划对保护公共卫生的贡献。
Based on the Agency's and industry'sexperience with the Guidance, the Center has developed the following questionsand answers. These should serve to clarify certain aspects of the document,specifically declarations of conformance to design controls and standards, andto promote consistency in the use of the Guidance. This question and answerdocument will be updated on a periodic basis to include frequently askedquestions and/or to provide the Agency's perspective on specific issues of theParadigm.
根据机构和行业的指导经验，该中心已经开发了以下问题和答案。这些应用于澄清文件的某些方面，特别是声明符合设计控制和标准，并促进使用指南的一致性。这个问答文件将定期更新，包括常见问题和/或提供机构对范式具体问题的看法。
At the end of this question and answerdocument, an example of a Special 510(k) for a cardiovascular catheter and aguidance document to be used in preparing an Abbreviated 510(k) for a latexcondom can be found. These documents were developed with the aid of theregulated industry to help illustrate the two new alternatives to theTraditional 510(k).
在该问题和答案文件的最后，可以找到用于心血管导管的特殊510（k）和用于制备乳胶避孕套的缩简510（k）的指导文件的示例。这些文件是在受监管行业的帮助下开发的，以帮助说明传统510（k）的两个新选择。
一般问题
根据机构第三方试点计划，特殊510（k）和缩简510（k）是否符合资格审查？
Both Special and Abbreviated 510(k)s may bereviewed under the Third Party Pilot Program as long as the 510(k)s are fordevices that are included in that program. Given that the Agency has committedto a 30 day review of Special 510(k)s, however, there may be no real advantageto using Third Parties to review this particular type of submission.
只要510（k）是用于该程序中包含的器械，则可以在第三方试点计划下对特殊和缩简510（k）进行审查。鉴于机构承诺对特殊510（k）进行30天的审查，使用第三方审查这种特定类型的提交可能没有实际的优势。
Note: Manufacturers should not confuse thereview of select 510(k)s by Third Parties with third party involvement inassessing conformance with design controls or standards. This latter topic isdiscussed in more detail in response to question #4.
注意：制造商不应该将第三方选择510（k）的审查与第三方参与评估符合设计控制或标准的情况混淆。后一个话题问题＃4将进行更详细的讨论。
FDA可以根据缩简或特殊510（k）中的基本等效性确定一致性声明吗，如果制造商声明他们将符合而不是符合规定？
The Food and Drug AdministrationModernization Act of 1997 added section 514 (c) Recognition of a Standard to the Federal Food Drug andCosmetic Act (the act). According to this section of the act, a declaration ofconformity to a recognized standard must certify that the device is inconformance. Therefore, in order for the Center to rely upon a declaration ofconformity to a standard in making a substantial equivalence (SE) determinationin an Abbreviated 510(k), the declaration must indicate that the submitter isin conformance. The Agency has adopted this same approach for Special 510(k)s.That is, a manufacturer may not state that they will conform at some futuredate, but rather conformance must have already been determined at the time theapplication is submitted.
1997年“食品和药物管理现代化法案”增加了第514（c）条“联邦食品药物和化妆品法案（该法案）”的标准。根据该法案的这一部分，符合认可标准的声明必须证明器械符合规定。因此，为了使中心在缩简510（k）中作出实质等效性（SE）确定的依据的标准符合声明，声明必须表明提交者符合规定。机构对特殊510（k）采用了同样的做法。也就是说，制造商可能不会声明他们将来在某个日期将符合，但是在提交申请时必须已经确定一致性。
It should be noted that declarationsindicating that a device/firm will conform to a standard/design controls hasbeen the most common reason that a submission has not been accepted for reviewas either an Abbreviated or Special 510(k), respectively.
应该指出的是，指示设备/企业将符合标准/设计控制的声明是最常见的原因，作为缩简或特殊的510（k），提交材料未被接受为复审。
如果缩简510（k）包含表示器械将符合但尚未符合标准的声明会发生什么？
As stated above, for issues material to thesubstantial equivalence determination, the Agency would not be able to relyupon such a statement. A declaration of conformity certifying that the deviceis in conformity to the standard would be needed.
如上所述，对于重大等同性裁定的问题，机构将无法依赖这种声明。将需要符合性声明，证明器械符合标准。
The only exception to the above would be forcases where substantial equivalence had previously been demonstrated fordevices of this type without conformance to the standard. For example, if amanufacturer states that a device will conform to IEC-60601-1-2 ElectromagneticCompatibility and substantial equivalence for the predicate device had beendetermined without conformance to the standard, then the submission could bereviewed as an Abbreviated 510(k). If, as stated above, conformance to thisstandard is integral to the SE determination, then conformance would need to beestablished before the 510(k) is submitted.
上述情况的唯一例外情况是，在不符合标准的情况下，先前已经对此类器械进行了实质性的等效性验证。例如，如果制造商声明器械符合IEC-60601-1-2“电磁兼容性”，并且确定了特定器械的实质等效性，而不符合标准，则可将该提交作为缩简510（k）。如上所述，如果符合本标准SE决定的组成部分，则在提交510（k）之前需要确定一致性。
如果有的话，企业有什么优势使用第三方来评估设计控制或认可标准的一致性？如果公司确实使用第三方进行评估，是否应将该信息包含在510（k）提交中？
Many device manufacturers employ thirdparties in assessing conformance with design controls or standards as a matterof routine practice. Although it is ultimately the submitter's responsibilityfor assuring conformance when electing to submit a declaration of conformity ina premarket submission, third party involvement may provide the manufacturerwith added confidence when submitting a declaration and provide the Agency withadditional assurance of conformance.
许多器械制造商都采用第三方来评估与设计控制或标准的一致性作为常规做法。尽管最终提交者有责任在选择上市前提交之前一致性声明时确保一致性，但第三方参与可能会在提交声明时向制造商提供更多的信心，并向机构提供额外的一致性保证。
Involvement by an independent, technicallycompetent third party can only benefit the overall process. In The New 510(k)Paradigm, it is stated that if a manufacturer uses a third party to perform aconformance assessment of design control requirements or standards, thisinformation should be maintained in the firm's device master record (DMR).In Attachment4of the document, however, it is stated that the declaration to conformityto a recognized standard should include the name and address of any testlaboratory or certification body involved in the conformance assessment as wellas a reference to the accreditation of the third party. To clarify this issue,the Agency recommends that 510(k) submitters follow Attachment2 and 4,when preparing declarations of conformity to design controls and standards,respectively. Thus, declarations of conformity to standards should include thename, address, and accreditation of all third parties involved in theconformance assessment. Declarations of conformity to design controls, however,would not need to include this information.
一个独立的，技术上有能力的第三方的参与能使整个过程受益。在新的510（k）范式中，指出如果制造商使用第三方对设计控制要求或标准进行一致性评估，则该信息应保留在公司的器械主记录（DMR）中。然而，在文件的附件4中，声明符合认可标准的声明应包括符合性评估中涉及的任何检测实验室或认证机构的名称和地址，以及对第三方认证的参考。为了澄清这个问题，机构建议510（k）提交者在编制与设计控制和标准一致性的声明时遵循附件2和4。因此，符合标准的声明应包括符合性评估中涉及的所有第三方的名称，地址和认证。然而，符合设计控制的声明不需要包括这些信息。
如果机构确定不能对特殊或缩简510（k）进行审查，会发生什么？提交是否被拒绝？审查是否重置？
If the Agency determines that a Special oran Abbreviated 510(k) is not eligible for review as submitted, the reviewerwill notify the firm of this decision and offer the option of having thedocument converted to a Traditional 510(k) or withdrawing it for futuresubmission. If the 510(k) is converted, the original receipt date remains asthe start of the review period. Manufacturers should be aware that, in mostcases, additional information will be necessary for converted documents.
如果机构确定特别或缩简510（k）不符合提交的审查资格，审查人员将通知公司此决定，并提供使文件转换为传统510（k）或撤回该文件的选项供未来提交。如果510（k）被转换，则原始收据日期仍然作为审查期间的开始。制造商应该意识到，在大多数情况下，转换文件需要更多的信息。
特殊510（k）相关问题
对于特殊的510（k），指导文件附件2规定，制造商的符合性声明应包括“所有验证和验证活动都执行...”的声明。由于这些活动中的某些活动直到市场营销才通常才能执行，因此在提交特殊510（k）之前应该执行哪些活动？
This statement in the declaration ofconformity is intended to capture the manufacturer's compliance with those verificationand validation activities that are related to the design modification(s).Therefore, prior to submission of a Special 510(k), FDA would expect that theverification and validation activities, as identified by the risk analysis toensure that the modified device is as safe and effective as the predicatedevice, would be completed and would demonstrate that the predeterminedacceptance criteria had been met. In accordance with the Quality SystemRegulation, however, all process validation must becompleted and appropriately documented before commercialization of the device.
一致性中的声明旨在捕获制造商遵守与设计修改相关的验证和验证活动。因此，在提交特殊510（k）之前，FDA将期望由风险分析确定的确保修改的器械与特定器械一样安全和有效的验证和验证活动被完成，并将表明已达到预定的验收标准。然而，根据“质量体系法规”，所有过程验证必须在器械商业化之前完成并妥善记录。
如果一家公司获得特殊510（k）的清关，那么企业是否必须进行检查，以验证是否符合设计控制？
No. The Office of Compliance is developingan audit program to help determine if firms that submitted Special 510(k)s werein fact in conformance with design control requirements. This does not mean,however, that all firms that submit Special 510(k)s will be audited. Under thepilot program, a limited number of cleared submissions will be identified for verificationof conformance with design controls by inspection. If a firm is to beinspected, the Agency will notify the firm ahead of time and follow establishedGMP inspection procedures.
不是的。合规办公室正在制定一个审查计划，以帮助确定提交特殊510（k）的企业是否实际上符合设计控制要求。但这并不意味着所有提交特殊510（k）的公司都将被审查。根据试点方案，将通过检查确定有限数量的清关提交文件，以验证是否符合设计控制。如果要检查公司，机构将提前通知公司，并按照GMP的检查程序进行。
Having stated the above, manufacturers arereminded that routine GMP inspections for Class II and III devices are requiredby the statute. Thus, submitters of 510(k)s for such devices are subject toinspection whether the premarket notification is submitted for review as anAbbreviated, a Special, or a Traditional 510(k).
根据上述说明，制造商被提醒，法规要求对II类和III类器械进行常规GMP检查。因此，对于这种器械的510（k）提交者，可以检查上市前通知是否被提交作为缩简，特殊或传统510（k）进行审查。
对于提交的特殊510（k），但后来决定不符合审查，产生这种决定最常见的原因是什么？
The most frequently observed problem withSpecial 510(k)s has been related to the design control information that wassubmitted in support of the device modification. Several submissions did notinclude a complete declaration of conformity to design controls. Othersubmissions included a statement indicating that the firm would comply with thedesign control requirements rather than a statement that the firm is inconformance. In a few 510(k)s, it was determined that the firm did not performa complete risk analysis for the device modification.
特殊510（k）最常观察到的问题是与提交支持器械修改的设计控制信息有关。一些提交的内容没有包括完整的设计控制符合性声明。其他提交的内容包括声明，表明该公司将遵守设计控制要求，而不是公司符合规定的声明。一些510（k），确定该公司没有对器械修改进行完整的风险分析。
Finally, one of the other problems observedwith the Special 510(k)s that have been submitted for review has been relatedto the device modification that is the subject of the submission. As discussedin the Guidance, changes to the intended use and fundamental scientifictechnology should be submitted as Abbreviated or Traditional 510(k)s ratherthan as Special 510(k)s. Several of the Special 510(k)s that were submittedincluded a change to either the intended use or to the fundamental scientifictechnology.
最后，提交审查的特殊510（k）所观察到的其他问题之一与提交的器械修改有关。如“指南”中所述，预期用途和基础科学技术的变更应以缩简或传统510（k）而不是特殊510（k）的形式提交。提交的个别特殊510（k）数据包括对预期用途或基础科学技术的改变。
与缩简510（k）相关问题
FDA认可了多少标准？目前公认的标准清单在哪里可以找到？
FDA has recognized approximately 400standards to which 510(k) submitters can declare conformity. The list of thesestandards can be found at on the World Wide Web at:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.The Agency will update this list on a periodic basis.
FDA已经确认了大约400个标准，510（k）提交者可以声明一致性。这些标准的清单可在网上找到：http：//www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm。机构将定期更新这一清单。
特殊510（k）的30天审查时间是否也适用于缩简510（k）s？
No. While the Agency expects thatdeclarations of conformity to standards will reduce the review time forAbbreviated 510(k)s compared to Traditional 510(k)s, FDA did not establish a 30day review clock for Abbreviated 510(k)s.
不适用。虽然机构预计，与传统510（k）相比，符合标准的声明将减少缩简510（k）的审查时间，但FDA没有为缩简510（k）建立30天审查时间。
如果符合标准的声明证明是假的信息，提交者是否需要承担责任？如果信息由第三方提供给提交者怎么办？提交虚假的符合性声明的后果是什么？
Yes. Submitting a false declaration ofconformity to a standard is specifically identified as a prohibited act insection 301(x) of the act. Ifit is determined that the information underlying the declaration of conformityis false or misleading in any material respect, the submitter of thedeclaration could be held liable. This is true whether the information wasgenerated by the submitter or by a third party (e.g., a testing facility).Therefore, it is important that a person declaring conformity to a standardcarefully review the information forming the basis for the declaration beforeit is submitted to the Agency.
是的，需要承担责任。提交符合标准的虚假声明在该法案第301（x）条中被明确指定为禁止行为。如果确定在符合性声明的基础上的信息在任何重大方面是虚假的或具有误导性的，则该声明的提交者可能需要承担责任。无论信息是由提交者还是由第三方（例如测试机构）生成，都是如此。因此，在向机构提交报告之前，宣布符合标准的人员应仔细审查构成声明基础的信息。
Having stated the above, the Agency does wishto distinguish a "false" or "misleading" declaration ofconformity from a declaration of conformity in which FDA disagrees with theadequacy of the supporting data. The Agency acknowledges that a manufacturermay make a good faith effort to conform with a standard and yet FDA maydisagree with the basis upon which the declaration was made. Under suchcircumstances, the Agency will make every effort to resolve the issue with thesubmitter.
在上述情况之后，机构希望区分“不合格声明”或“误导性”的一致性声明，其中的一致性声明不符合FDA的支持数据。机构承认，制造商需要诚实地努力，以符合标准，但FDA可能不同意作出声明的依据。在这种情况下，机构将尽一切努力解决提交者的问题。
在审查510（k）期间，FDA是否会定期要求支持符合标准声明的数据或信息？
Section 514 of the act authorizes the Agencyto request, at any time, data or information relied upon for the declaration ofconformity. FDA does not, however, expect that this would routinely occur, butrather only on a case-by-case basis if a serious concern arises during thereview of the submission. The concurrence of senior management would be neededbefore such a request would be made.
该法案第514条授权机构随时要求提供符合声明的数据或资料。然而，FDA并不希望这样做，而是仅在逐案审查的情况下出现严重问题。在提出要求之前，需要高级管理层的同意。
支持符合标准声明的记录需要保持多长时间？
Section 514 of the act requires personsdeclaring conformity to a standard to maintain data and informationdemonstrating conformity of the device to the standard for two years after thedate of the substantial equivalency determination or for a period equal to theexpected design life of the device, whichever is longer.
该法案第514条规定，宣称符合标准的人员在实质等效性确定之日起两年后，或在等于器械的预期设计寿命的期限内，保持数据和信息以显示器械与标准的一致性，以较长者为准。
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