FDA Sounds Alarm on Fraudulent Testing Data at Third-party Labs

By Amelia Boldrick and Sarah Fitzgerald

The U.S. Food and Drug Administration (FDA) published a letter to industry reminding device manufacturers and sponsors of medical device studies to use caution when selecting third-party laboratories to conduct verification and validation testing. The letter noted that in recent years the regulator has identified what they refer to as an “alarming trend” in the number of premarket submissions with falsified and unreliable testing data.

FDA research oversight overseas

The letter noted that additional action would be pursued through the Office of Bioresearch Monitoring Program, or BIMO, which serves as the unified research compliance hub for the FDA. The auditing and inspection program operates internationally and oversees the integrity of the data provided in FDA premarket submissions. The FDA stated that it has concerns with multiple laboratories in China and India, but did not identify any specific facilities by name.

Unreliable data blocks patient access to devices

The agency emphasized the responsibility of device manufacturers for the truthfulness and accuracy of the information provided in submissions. It elaborated that manufacturers are expected to evaluate inconsistent or improbable data from third-party testers and determine if additional testing may be required. It further stressed the negative impact of fraudulent data on patients, their access to new devices and the risk posed to the supply chain when submissions are refused. The letter calls upon manufacturers to consider third-party laboratories accredited under the voluntary Accreditation Scheme for Conformity Assessment (ASCA) and to independently assess the results of all third-party testing.

Data quality essential to successful market entry

The quality of data provided in a premarket submission is integral to a successful market entry. Testing laboratories should be evaluated as suppliers in alignment with a company’s quality management system, and ASCA-accredited laboratories should be considered. Additionally, test reports should be evaluated before submission to the FDA.