FDA 对于生物相容性的要求

2024-11-09

最近讨论最多的关于生物相容的问题莫FDA对于国内两家试验室的warning letter了，抛开这两家试验室本身是否有问题不说，今天我们开看看FDA 对于生物相容性的要求。

其实在去年9月FDA 发布关于如何使用ISO 10993-1来做做生物学评价指南文件的时候，酒茶客就写过一篇小结，来分析FDA 关于生物学评价的要求其实不能仅仅只限于ISO 10993-1的要求。

没想到过了一年FDA 对于生物学评价的要求从单纯对制造商的要求开始延伸到了对相关实验室的要求，在曝出国内实验室问题之后，紧接着FDA 就发布（或者说更新）了三个相关的ASCA指南文件的征求意见稿，其中就包含了生物相容性测试的指南文件

大家需要注意的是，虽然这个仅是针对ASCA 项目中的生物学相容测试的要求，但是因为很多的ASCA 项目中的认可的标准也同时在美国认可共识性标准清单上，所以大家提交FDA 注册的时候即使不走ASCA项目，也同样可以参照ASCA 指南文件中的要求来规划自己的生物相容性测试。

下面是ASCA 项目认可的生物相容性标准清单：

而整个FDA 认可共识标准关于生物相容性方面的标准一共有如下26个，还需要注意FDA并不是每个标准都是整个接受的，部分标准是部分接受，具体的差异部分或者说FD额外要求的细节就需要进SIS 中去仔细研究了。

Extent of Recognition	iso	Standard Designation Number/Date	Title of Standard	Transition Expiration Date
Partial	ISO	10993-17 Second edition 2023-09	Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
Complete	ISO	10993-2 Third edition 2022-11	Biological Evaluation of medical devices - Part 2: Animal welfare requirements
Complete	ISO	10993-12 Fifth edition 2021-01	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Partial	ISO	10993-10 Fourth edition 2021-11	Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Partial	ISO	10993-18 Second edition 2020-01 Amendment 1 2022-05	Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
Partial	ISO	10993-23 First edition 2021-01	Biological evaluation of medical devices - Part 23: Tests for irritation
Complete	ISO	TS 10993-19 Second edition 2020-03	Biological evaluation of medical devices - Part 19: Physico-chemical morphological and topographical characterization of materials
Partial	ISO	10993-15 Second edition 2019-11	Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
Complete	ISO	10993-9 Third edition 2019-11	Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Complete	ISO	10993-7 Second edition 2008-10-15	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009) AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
Partial	ISO	10993-18 Second edition 2020-01	Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.	12/21/2025
Partial	ISO	10993-1 Fifth edition 2018-08	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Complete	ISO	10993-11 Third edition 2017-09	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Complete	ISO	10993-16 Third edition 2017-05	Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Complete	ISO	10993-6 Third edition 2016-12-01	Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
Complete	ISO	10993-4 Third edition 2017-04	Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
Complete	ISO	10993-5 Third edition 2009-06-01	Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Partial	ISO	10993-13 Second edition 2010-06-15	Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Complete	ISO	10993-14 First edition 2001-11-15	Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
Complete	ISO	10993-10 Third Edition 2010-08-01	Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	12/22/2024
Partial	ISO	10993-12 Fourth edition 2012-07-01	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials	12/22/2024
Complete	ISO	10993-2 Second edition 2006-07-15	Biological Evaluation of medical devices - Part 2: Animal welfare requirements	07/05/2026
Partial	ISO	10993-3 Third edition 2014-10-1	Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity
Partial	ISO	10993-17 First edition 2002-12-01	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances	12/20/2026
Partial	ISO	TS 10993-20 First edition 2006-08-01	Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
Partial	ISO	TR 10993-33 First Edition 2015-03-01	Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3

所以总结一下：

如果做FDA 注册，你可以考虑走ASCA 项目或者不走，如果走，那么你就需要看ASCA认可的生物相容性标准要求，并找ASCA 认可的生物相容性实验室，一个不好的消息就是ASCA 认可的生物相容性试验室目前全球只有5家。
走不了ASCA 的话那就老老实实走传统的，但是也需要关注ISO 10993-1的指南文件中的FDA特殊要求来做好自己的生物学评价计划，找出适用的标准同时，在仔细研究FDA对于每个特定的标准是否是全部接受还是部分接受的，要针对特殊部分计划好测试方案。至于实验室的选择的话，没有ASCA 的就尽量找A2LA吧，不然可能在后期的审核中会有不必要的麻烦。

责任编辑：邵丽竹

审　　核：何发

FDA 对于生物相容性的要求

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