Medical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. The agency declared that it has identified an increase in fraudulent and unreliable laboratory testing data within these submissions.

It advised manufacturers and study sponsors for these products to “carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA.”

This was communicated in a Letter to Industry (medical devices) published by the agency on 20 February 2024.

Ensuring data integrity of medical devices

FDA emphasised that these firms are responsible for qualifying third parties that generate data and to ensure that all information submitted to the FDA is truthful and accurate.

In recent years, there has been an increasing trend where “entities that contract with device firms to conduct testing on medical devices are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable”, the organisation noted.

Consequently, because “it calls into question the data integrity of the entire file”, FDA asserted that is unable to rely on the data to grant marketing authorisation.

As such, FDA highlighted that all testing data that a firm does not perform itself should be examined, “especially relating to biocompatibility and other performance testing”.

The agency did acknowledge that it may be challenging for individual device firms to confirm if certain data has been copied from an unrelated marketing submission. However, it expects 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.”

To ensure medical devices are safe, effective and high-quality, in its letter, the FDA stated that it is taking “various actions” to identify and confront data integrity violations.

Overall, the FDA called for medical device industry to “be vigilant and proactive about ensuring the integrity of all data they include in medical device submissions.”

Ensuring safety and efficacy of medical devices

UK perspective

Medical Devices/IVDs Regulatory Quality and Clinical Consultant, Shweta Agarwal, remarked on LinkedIn about a recent MedTech Regulatory Reform webinar by the MHRA.

From her perspective, when considering the future of medical device regulations in the UK, the updates “reflect a proactive approach to regulatory reform, prioritising safety and efficacy in medical device development”.

Specifically, the “MHRA is taking steps to align the scope of medical device regulations with international practices, particularly the EU medical device regulation (MDR). This means updating the definition of medical devices to ensure consistency across borders.”

Additionally, Agarwal noted that positively: “The essential requirements will be aligned with the general safety and performance requirements (GSPRs) of the EU MDR, ensuring stringent standards are met.”

In conclusion, it is clear US and UK regulators are working to streamline guidelines to ensure the quality and thus safety of medical devices that are made available.