当地时间2024年2月20日，FDA发布一则通讯，FDA提醒医疗器械生产商仔细审查第三方的数据：上市前提交中的欺诈性和不可靠的实验室检测数据
The U.S. Food and Drug Administration (FDA) is reminding sponsors of device studies and manufacturers of devices (“device firms”) to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA. It is the responsibility of device firms to qualify third parties that generate data and to ensure that all information submitted to the FDA is truthful and accurate.
美国食品和药物管理局 (FDA)提醒器械研究的发起人和器械制造商(“器械公司”) 仔细评估参与产品性能性能测试的第三方，并在提交给FDA之前独立核实所有测试结果。器械公司有责任对提供数据的第三方进行资格审查，并确保提交给FDA的所有信息是真实和准确的。
In recent years, the FDA has observed that an increasing number of entities that contract with device firms to conduct testing on medical devices (“third-party test labs”) are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable. When such data are submitted to the FDA, the agency is unable to rely on them to grant marketing authorization and it calls into question the data integrity of the entire file.
近年来，FDA观察到越来越多的实体(“第三方测试实验室”)与器械公司签约进行医疗器械测试，生成的测试数据是伪造的、复制其他器械提交的（数据），或者是其它不可靠的测试。当这些数据提交给FDA时，该机构无法依靠它们来授予营销授权，并对整个文件的数据完整性提出质疑。
The FDA has identified an increase in submissions containing unreliable data generated by third-party test labs, including from numerous such facilities based in China and India. This alarming trend has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions include such data. Sponsors and manufacturers making submissions are obviously directly impacted in these cases when the device cannot be authorized. An additional effect of these negative decisions is reduced access to new devices for patients and healthcare providers and potential disruption in the supply chains for devices. Device firms need to be diligent in order for this to stop.
FDA发现，第三方测试实验室（包括中国和印度的众多此类机构）提交的包含不可靠数据的材料有所增加。这一令人担忧的趋势导致FDA无法对提交的包括此类数据的医疗器械做出实质等同的等效性决定，或以其它方式授权其上市。在这些情况下，当器械不能获得授权时，提交的发起方和制造商显然会受到直接影响。这些负面决定的另一个影响是减少了患者和医疗服务提供者获得新器械的机会，并可能破坏器械的供应链。医疗器械公司需要努力制止这种情况。
To reverse the trend of unreliable data being submitted to the FDA, it is incumbent on device firms to take proactive steps to qualify third-party test labs and to closely scrutinize all testing data that a firm does not perform itself, especially relating to biocompatibility and other performance testing, that are included in a submission to the FDA. We acknowledge it may be difficult for individual device firms to know if certain data have been copied from an unrelated marketing submission, but we expect device firms to identify testing results that are improbable or impossible on their face or do not seem consistent with known information about the device. While the FDA encourages device firms to partner with third-party labs that have been voluntarily accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program, doing such does not substitute for conducting an independent assessment of all third-party data.
为了扭转向FDA提交不可靠数据的趋势，医疗器械公司有责任采取积极措施，对第三方测试实验室进行资格认证，并仔细审查所有公司未自行实施测试的所有数据。特别是与生物相容性和其他性能有关的测试数据。这些数据包括在提交给FDA的文件中。我们承认，对于个别器械公司来说，可能很难知道某些数据是否是从不相关的上市提交中复制的，但我们希望器械公司能够识别出表面上看不太可能或不可能的测试结果，或者似乎与器械已知信息不一致的测试结果。虽然FDA鼓励器械公司与根据符合性评估认证计划(ASCA)自愿认证的第三方实验室合作，但这样做并不能取代对所有第三方数据进行独立评估。
To protect patients and healthcare providers from substandard products and ensure that U.S. patients have access to safe, effective, and high-quality medical devices, the FDA is pursuing various actions to identify and confront data integrity violations including through our Bioresearch Monitoring Program. At the same time, the FDA is calling upon the medical device industry to be vigilant and proactive about ensuring the integrity of all data they include in medical device submissions.
为了保护患者和医疗保健机构免受不合格产品的危害，并确保美国患者能够获得安全、有效和高质量的医疗器械，FDA正在采取各种行动，包括通过我们的生物研究监测计划，来识别和应对数据完整性违规行为。同时，FDA呼吁医疗器械行业保持警惕，并积极主动地确保他们在医疗器械提交中包括的所有数据的完整性。
从上面的通知可知，FDA对测试数据的真实性和完整性核查非常重视及严格，这也要求企业和服务机构对测试数据的真实性和完整性引起足够的重视。同时，做为医疗器械的从业者要建立基本的道德底线和职业操守。
其次，在选择实验室时，要非常谨慎。在决定合作前，不仅要确认实验室的资质，还要确认是否有同类产品的测试经验，对产品和标准要求是否熟悉，以保证测试报告的质量。
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