Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here. This was followed last September with warning letters issued to two Chinese firms performing biocompatibility testing, citing violations of 21 C.F.R. Part 58 – Good Laboratory Practices Nonclinical Laboratory Studies, regarding concerns about the quality and integrity of data generated by the labs.
FDA has recently issued an updated Notifications on Data Integrity – Medical Devices. Within the Notification, FDA references a General Correspondence Letter (GCL) sent on February 26, 2025.
In the GCL, FDA notes it has identified multiple test reports from studies that include "cytotoxicity studies that contain identical or nearly identical results from different dates, sensitization studies (Guinea Pig Maximization Tests) that contain identical sets of guinea pig pretreatment body weights for different groups on different dates, and a large animal safety and performance study for a staple line reinforcement device that contains implausible bleeding assessments and pre-to-post procedure weight gains in Bama pigs." FDA states that it has no reason to believe that any data are reliable. The GCL indicates that data will be rejected until the lab demonstrates that the issues described are adequately addressed.
FDA's Notification states that it has identified unreliable testing data during review of 510(k)s, which has resulted in FDA being unable to clear the device. As in the earlier letter to industry, the current FDA Notification recommends that sponsors of device studies and manufacturers of devices "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." As discussed in the previous post, this is easier said than done given many firms lack in house expertise, and it is impossible to identify if data in a report received may be identical to data that the third party has provided to another sponsor.
Given FDA's continued focus on data integrity, sponsors should check to be sure there have been no issues raised with third party labs they are using prior to testing. We'll continue to follow this issue.
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