FDA注册时生物相容(Biocompatibility)研究的准备要求-麦祥官网|医疗器械国际注册及境外临床运营CRO

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生物相容评估是FDA审核器械安全的重要的指标，是器械产品能否获得批准的决定因素。下面我们就分享下FDA对于准备生物相容评估的基本步骤和重要因素的理解：

Step 1:基本知识

什么情形下才需要生物安全评估？

只有器械和身体组织由直接或间接接触时， FDA才会对产品进行生物相容评估。

FDA生物相容评估的内容是什么？

FDA在评估器械的组成材料是否会与身体接触可能导致不良的生物反应。

FDA如何评估生物相容？

FDA的策略是评估器械产品的整体生物相容，而不是产品的某一部分。评估包括原材料，原材料处理，生产工艺以及生产过程遗留的微量成分。FDA强烈建议阅读FDA 对于ISO 10993-1的指导文件： FDA’s Biocompatibility Guidanceon Use of ISO 10993-1

通常，FDA感兴趣的生物相容性因素为：

- 接触性质(Nature of contact)

- 接触类型(Type of contact): 直接/间接？

- 接触的频率和时长 (Frequency and duration of contact)

- 材料 (Materials)

Step 2:如何决定生物相容测试的终点（endpoints）呢?

总体上FDA 会从两个方面决定生物相容研究的终点:

（1）接触类型:

Surface Device

Surface Device: Intact Skin

Surface Device: Mucosal Membrane

Surface Device: Breached or Compromised Surface

External Communicating Device

External Communicating Device: Blood Path, Indirect

External Communicating Device: Tissue/Blood/Dentin

External Communicating Device: Circulating Blood

Implant Device

Implant Device: Tissue/Bone

Implant Device: Blood

（2）接触时长：

Limited: Less than or equal to 24 hours

Prolonged: Greater than 24 hours to 30 days

Long-term/Permanent: More than 30 days

每个类型需要做的具体生物相容测试请详见FDA’s Biocompatibility Guidanceon Use of ISO 10993-1

Step 3:对比测试或市场产品：

FDA提供了几个范例来记录对比测试/市场产品

成分记录 (component documentation)

Comparison Type	Sample Statement
Comparison to test article	“The [polymer/metal/ceramic/composite name] [component name] of the test article is identical to the *[component name]* of the medical device in its final finished form in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).”
Comparison to previously marketed device	“The [polymer/metal/ceramic/composite name] [component name] of the medical device in its final finished form is identical to the *[component name]* of the *[name]* (legally US-marketed device) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).”

器械记录 (Device documentation)

Comparison Type	Sample Statement
Comparison to test article	“The test article is identical to the medical device in its final finished form in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).”
Comparison to previously marketed device	“The medical device in its final finished form is identical to [name] (previously marketed device) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).”

加工或灭菌方式改动

Comparison Type	Sample Statement
Comparison to test article	"…with the exception of *[identify change].* FDA submission exhibit [#], page *[#]*, submitted on [date], provides scientific information to demonstrate that the [processing/sterilization] change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the test article can be applied to the medical device in its final finished form.”
Comparison to previously marketed device	"…with the exception of *[identify change].* FDA submission exhibit *[#], page [#], submitted on [date], provides scientific information to demonstrate that the [processing/sterilization]* change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the *[name]* (legally US-marketed device) can be applied to the medical device in its final finished form.”

配方改动

Comparison Type	Sample Statement
Comparison to test article	"…with the exception of *[identify change].* FDA submission exhibit *[#], page [#], submitted on [date]*, provides scientific information to demonstrate that the formulation change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the test article can be applied to the proposed medical device in its final finished form.”
Comparison to previously marketed device	"…with the exception of *[identify change].* FDA submission exhibit [#], page [#], submitted on *[date],* provides scientific information to demonstrate that the formulation change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the *[name]* (legally US-marketed device) can be applied to the medical device in its final finished form.”