我们在注册医疗器械时，都需要送检第三方测试产品的生物相容性等，这些检测报告是医疗器械注册技术审评中必交的技术文档，其合规性直接影响注册进度。

2025年5月22日，FDA发布了一则通告，涉及两家中国的检测机构。质疑检测机构的数据完整性，在检测机构未妥善解决这些问题之前，FDA将拒绝接受其参与的所有研究数据。我们在申请FDA注册时，需要暂时规避风险。

Notifications on Data Integrity – Medical Devices

通知: 关于医疗器械数据完整性的重要提示

The FDA’s Center for Devices and Radiological Health (CDRH) is vigilant in ensuring data submitted to the FDA can be relied upon to assess the effectiveness, safety, or risk of a device. The FDA has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors. This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions rely on such data. In addition to obvious negative impacts to sponsors, these adverse determinations caused by unreliable testing data may also delay or reduce access to new devices that the FDA ultimately authorizes for patients and health care providers and increase the potential for disruption in the supply chains for devices.

美国食品药品监督管理局（FDA）下属的器械与放射健康中心（CDRH）始终致力于确保提交至FDA的数据能够可靠地用于评估器械的有效性、安全性或风险。FDA注意到，由第三方检测机构代表器械制造商和申请人出具的不可靠测试数据数量有所增加。这导致FDA无法对依赖此类数据的医疗器械提交材料做出实质性等同认定或其他上市批准决定。除了对申请人造成明显负面影响外，这些由不可靠测试数据导致的否定性判定还可能会延迟或减少患者和医疗机构最终获得FDA授权的新器械的机会，并增加器械供应链中断的风险。

Sponsors of device studies and manufacturers of devices are reminded to carefully evaluate the third parties they engage to conduct safety, performance, and cybersecurity testing and to independently verify all testing results before submitting to the FDA.

器械研究申请人和器械制造商应注意，务必审慎评估承接安全性、性能及网络安全测试的第三方机构，并在向FDA提交前独立验证所有测试结果。

The FDA remains committed to taking appropriate actions to address ongoing data integrity concerns.

FDA仍持续采取适当措施应对数据完整性问题。

FDA has Issued the Following Letters on Data Integrity

FDA已发布以下关于数据完整性的函件

General Correspondence Letter Issued to Sanitation & Environment Technology Institute of Soochow University dba SDWH.

致苏州苏大卫生与环境技术研究所有限公司的通用函件

The FDA determined that Sanitation & Environment Technology Institute of Soochow University dba SDWH (苏州苏大卫生与环境技术研究所有限公司 - Suzhou Suda Weisheng Yu Huanjing Jishu Yanjiusuo Youxian Gongsi) has in several instances copied the results of another study or created falsified or otherwise invalid data that was submitted to the FDA. Until the firm adequately addresses these issues, all study data from all studies conducted at this testing facility will be rejected. 

FDA认定苏州苏大卫生与环境技术研究所有限公司（简称SDWH）在多起案例中复制其他研究结果或伪造/提交无效数据。在该检测机构未妥善解决这些问题之前，FDA将拒绝接受其参与的所有研究数据。

General Correspondence Letter Issued to Mid-Link Technology Testing Co., Ltd.

致天津海河标测技术检测有限公司的通用函件

The FDA determined that Mid-Link Technology Testing Co., Ltd., (天津海河标测技术检测有限公司 - Tianjin Haihe Biaoce Jishu Jiance Youxian Gongsi) has in several instances copied the results of another study or created falsified or otherwise invalid data that was submitted to the FDA. Until the firm adequately addresses these issues, all study data from all studies conducted at this testing facility will be rejected.  

FDA认定天津海河标测技术检测有限公司（Mid-Link Technology Testing Co., Ltd.）在多起案例中复制其他研究结果或伪造/提交无效数据。在该测试机构未妥善解决这些问题前，FDA将拒绝接受其参与的所有研究数据。

Additional Resources

其他资源

FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing Firms

FDA针对两家中国第三方检测机构的数据完整性问题采取行动

Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data

上市前申请中的欺诈性和不可靠实验室测试数据：FDA提醒医疗器械制造商严格审查第三方生成数据

FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices | FDA