Scrutinising Third-Party-Generated Data: FDA Warning

Image credit: Yassine Khalfalli via Unsplash

Medtech innovators have been cautioned as to the importance of carefully evaluating any external parties engaged to conduct performance testing, and to ensure results are scrutinised and independently verified prior to a US Food and Drug Administration (FDA) submission.

The advice from the FDA followed a trend the agency said it had noticed of unreliable or fraudulent data generated via device companies contracting “third-party test labs” to conduct device testing.

“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,” said the FDA in its announcement on 20 February 2024.

“…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.”

Refer to the full announcement from the FDA, and check out this column from Med Device Online which further unpacks the potential impacts of unreliable lab testing data for innovators.