A complete description and adequate biocompatibility assessment is important because patient or user exposure to your device could result in adverse health effects. Therefore, please identify all indirect and direct tissue contacting components and materials of your device, including the chemical name. Chemical Abstracts Service (CAS) numbers, and, if available, the Safety Data Sheet (SDS) could be helpful to your response. Please also provide at least ONE of the following：

  对器械进行全面的描述并进行充分的生物相容性评估非常重要，因为患者或用户接触设备时可能会导致不良健康影响。因此，请列出器械中所有直接和间接与组织接触的组件及材料，包括化学名称。化学文摘服务（CAS）编号以及（如有）安全数据表（SDS）可能会对您的答复有所帮助。此外，请提供以下内容中的至少一项：

    a. For the entire device (if applicable), a statement that "The product in its final finished form is identical to the (legally US-marketed device) (please identify) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)." Of note, this option is only applicable for devices with materials and manufacturing procedures that are identical to a legally US-marketed device with the same nature and duration of tissue contact. This comparator device should be your own. Alternatively, you may provide a right to reference (from the comparator device’s owner) the proprietary information within the relevant FDA submission.

  对完整器械（如适用）而言，需进行如下声明：“该终产品与（已在美国合法上市的器械）（请具体指明）在配方、加工、灭菌和几何形状方面完全相同，且未添加其他化学物质（例如，增塑剂、填充剂、添加剂、清洁剂、脱模剂）。” 需要注意的是，此仅适用于材料和制造工艺与已在美国合法上市且具有相同组织接触性质和持续时间的器械完全相同的器械。此对比器械应为贵司的产品。或者，可以从对比器械的所有者处获得引用权（从对比器械的所有者处获取相关 FDA 提交文件中的专有信息）。

    b. For each tissue contacting component, a statement that "The component(s) of the medical device in its final finished form is identical to the (legally US-marketed device) (please identify) in formulation, processing, sterilization, and geometry, and no other chemicals have been added(e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)." Of note, this option is only applicable for devices with materials and manufacturing procedures that are identical to a legally US marketed device with the same nature and duration of tissue contact. This comparator device should be your own. Alternatively, you may provide a right to reference (from the comparator device’s owner) the proprietary information within the relevant FDA submission.

  对于每个与组织接触的部件，需进行如下声明：“该医疗器械最终成品中的部件（如有）在配方、加工、灭菌和几何形状方面与（已在美国合法上市的同类产品）（请具体指明）完全相同，且未添加其他化学物质（例如，增塑剂、填充剂、添加剂、清洁剂、脱模剂）。” 需要注意的是，此选项仅适用于材料和制造工艺与已在美国合法上市且具有相同性质和组织接触持续时间的同类产品完全相同的器械。此对照器械应由您自行提供。或者，您可以向对照器械的所有者请求提供（从对照器械中获取的）相关 FDA 提交文件中的专有信息。

    c. Identify a comparator device, describe differences in material composition, formulation, processing, sterilization, and/or geometry, and provide a rationale for why these differences are not expected to impact biocompatibility. If applicable, please also provide a rationale for why differences in nature or duration of tissue contact are not expected to impact biocompatibility. Please also be advised that depending on the identified differences and rationale provided, additional biocompatibility assessments may be requested to support the substantial equivalence of your device.

  确定一个对比器械，描述其在材料组成、配方、加工、灭菌以及/或几何形状方面的差异，并说明为何这些差异预计不会影响生物相容性。如适用，请同时说明为何组织接触的性质或持续时间方面的差异预计也不会影响生物相容性。此外，请注意，根据所确定的差异及所提供的理由，可能会要求进行额外的生物相容性评估以支持您的器械具有实质等效性。

    d. Information as described in Attachment G of FDA’s Biocompatibility Guidance related to included and excluded materials, manufacturing controls and labeling.

  与美国食品药品监督管理局《生物相容性指南》附件 G 中所描述的内容一致的信息，包括但不限于相关材料的纳入与排除、生产控制以及标签要求。

    e. If an adequate comparator cannot be identified for the indirect/direct patient contacting materials of the subject device, to support the biocompatibility of your device, please provide biocompatibility testing to represent all direct/indirect patient contacting materials per its contact classification. Alternatively, please provide a rationale for why the biocompatibility testing is not necessary to support biocompatibility of your device (including data from chemical characterization and toxicological risk assessment).

  若无法为涉及的器械的间接/直接患者接触材料找到合适的对比器械，以此器械的生物相容性安全性，请提供生物相容性测试结果，以涵盖所有直接/间接与患者接触的材料，并符合其接触分类标准。或者，请提供为何无需进行生物相容性测试来证明设备生物相容性的理由（包括化学特性分析和毒理学风险评估的数据）。

  注：已删除了产品相关的信息，仅保留了FDA对于生物相容性安全性评价的要求，如有不妥可联系作者。

  文章来源：医械生物学评价