The U.S. Food and Drug Administration (FDA) has issued a reminder to sponsors of device studies and manufacturers of devices (or “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.”
The FDA says that they have “observed an increasing number of entities that contract with device firms to conduct testing on medical devices” that generate testing data that are “fabricated, duplicated from other device submissions, or otherwise unreliable.” They specifically identify unreliable data generated by third-party test labs, “including from numerous such facilities based in China and India.”
This trend is attributable to the FDA “being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions include such data.” In turn, this leads to “reduced access to new devices for patients and healthcare providers and potential disruption in the supply chains for devices.”
The FDA calls on device firms to “qualify third-party test labs and to closely scrutinize all testing data that a firm does not perform itself.” While acknowledging the difficulty in determining whether or not “certain data have been copied from an unrelated marketing submission,” they call on 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.”
For its part, the FDA is “pursuing various actions to identify and confront data integrity violations” while also “calling upon the medical device industry to be vigilant and proactive about ensuring the integrity of all data they include in medical device submissions.”
The FDA’s website has the news release.
