Why the FDA is warning the medical device industry of "fraudulent" third-party data in device applications


In premarket submissions, data quality and data integrity is so important. Medical device companies are responsible to ensure their data is truthful and accurate.

In late February 2024, The Food and Drug Administration (FDA) issued a warning to medical device companies, urging them to take proactive steps to qualify third-party test labs, largely located in China and India, and closely scrutinize all external data.

Why? The FDA is issuing this warning due to the alarming trend they are seeing in the premarket submissions which has left them unable to authorize some medical devices.

What is this trend? The FDA has seen a rise in testing data that has been fabricated, duplicated from other device submissions or otherwise unreliable.

By including this data in premarket submissions, manufacturers, patients and healthcare providers are seeing a harmful delay in access to these devices and disrupting supply.

What is their suggestion? The FDA wants companies 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.”

The agency is encouraging device companies to work with the more than 100 third-party labs that are in its Accreditation Scheme for Conformity Assessment (ASCA). However, working with an ASCA-accredited lab “does not substitute for conducting an independent assessment of all third-party data,” the FDA said.

What steps is the FDA taking? Officials said the FDA is “pursuing various actions to identify and confront data integrity violations including through our Bioresearch Monitoring Program.”

RQMIS has helped many companies to review and verify their data and testing results ensuring data integrity. This has included successful defense during Biomedical Monitoring Audits, of clinical data collected during a Phase III Clinical Study.

Using this data, we have authored and successfully negotiated premarket submissions such as 501(k)s, De Novo Submissions, Premarket Approvals (PMA) and Investigational Device Exemptions (IDE).

We have assisted many with designing, implementing and managing their clinical studies in domestic and global labs, and in some cases helped our clients choose reliable testing labs.

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