The integrity of more third-party-generated data is being questioned, and the U.S. Food and Drug Administration (FDA) cannot rely on that data to issue marketing authorizations, the agency argues.
The U.S. Food and Drug Administration (FDA) recently highlighted data integrity issues regarding premarket applications received for medical devices. The agency announced that it had identified an increase in fraudulent and unreliable clinical test data among these submissions.
It recommended that manufacturers and research sponsors of these products “carefully evaluate the third parties they engage to conduct performance testing and independently verify all test results before submission to FDA.” .
This was communicated in a letter to the industry (medical devices) issued by the agency on February 20, 2024.
Ensuring data integrity for medical devices
FDA emphasized that these companies are responsible for certifying the third parties that generate the data and ensuring that all information submitted to FDA is true and accurate.
In recent years, “entities that contract with device companies to perform medical device testing have generated test data that is fabricated, copied from other device submissions, or otherwise unreliable.'' There is a growing trend of
In recent years, there has been a trend in which “companies that contract with device companies to conduct medical device testing are producing test data that is fabricated, copied from other device submissions, or otherwise unreliable.” The organization pointed out that the number of cases is increasing.
As a result, the FDA argued that it could not rely on that data to grant marketing authorization because it “raises questions about the integrity of the data in the entire file.”
Therefore, FDA emphasized the need to review all test data that companies do not perform themselves, especially data related to biocompatibility and other performance tests.
The agency acknowledged that it may be difficult for individual device companies to determine whether certain data was copied from unrelated marketing submissions. But the report expects device companies to “identify test results that are seemingly unlikely, impossible, or inconsistent with known information about the device.”
To ensure the safety, effectiveness, and high quality of medical devices, the FDA said in the letter that it is taking “a variety of actions” to identify and combat data integrity violations.
Overall, the FDA urged the medical device industry to be “vigilant and proactive in ensuring the integrity of all data contained in medical device submissions.”
Ensuring the safety and effectiveness of medical devices
British perspective
Medical Device/IVD Regulatory Quality and Clinical Consultant Shweta Agarwal commented on the MHRA's recent MedTech regulatory reform webinar on Linkedin.
From her perspective, considering the future of medical device regulation in the UK, the update “reflects a proactive approach to regulatory reform that prioritizes safety and efficacy in medical device development”. .
Specifically, 'the MHRA is taking steps to align the scope of medical device regulation with international practice, in particular the EU Medical Device Regulation (MDR). This is to ensure consistency across borders. This means updating the definition of a medical device.”
Further, Mr. Agarwal positively stated, “The essential requirements are in line with the General Safety and Performance Requirements (GSPR) of the EU MDR, ensuring that stringent standards are met.”
In conclusion, it is clear that US and UK regulatory authorities are working to streamline guidelines to ensure the quality and safety of medical devices provided.
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