Date Issued: February 20, 2024

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.

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.

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.

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.

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.

Questions?

If you have questions about this communication, contact the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov or 800-638-2041 or 301-796-7100.