Senior Vice President and Chief Quality Officer
In response to an “alarming trend” in regulatory submissions containing unreliable data generated by third-party test labs, the U.S. Food and Drug Administration (FDA) sent a Letter to Industry reminding Sponsors of device studies and Manufacturers of devices (“device firms”) to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA.
In their communication released on February 20, 2024, entitled “Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data”, the FDA noted “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.” They further stated, “While the FDA encourages device firms to partner with third-party labs that have been voluntarily accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program, doing such does not substitute for conducting an independent assessment of all third-party data.”
This reminder from FDA comes as they have observed that “an increasing number of entities that contract with device firms to conduct testing on medical devices (“third-party test labs”) are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable. When such data are submitted to the FDA, the agency is unable to rely on them to grant marketing authorization and it calls into question the data integrity of the entire file.”
The move for more stringent oversight is further supported by FDA’s Bioresearch Monitoring (BIMO) program, which was established, in part, to assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications. Through on-site inspections, data audits, and remote regulatory assessments, BIMO serves as a “cornerstone of the FDA preapproval process.”
How should sponsors and manufacturers respond?
In light of this increased scrutiny from FDA, Beaufort’s Clinical Monitoring Oversight solutions stand as a vital resource for medical device companies, providing a scope of services that aligns with the FDA’s call to action for proactive and independent assessments. Our team of experts offer clients an additional layer of vigilance through an objective review of all third-party activities and performance.. We deploy local oversight monitors to conduct thorough on-site visit evaluations and assessments, collecting actionable insights to swiftly pinpoint and rectify non-conformances, affirm data integrity, and maintain trial timelines.
Our approach to mitigating regulatory risks that could compromise trial data, participant safety, and submission viability utilizes a rigorous process that includes:
- Clinical Monitoring Oversight Plan Development
- Strategic Site and Partner Selection
- On-site Performance Evaluation
- Real-time Metrics and Analysis
- End-of-Trial Reporting and Inspection Readiness
Ultimately, our primary purpose is to help ensure the acceptability of trials for regulatory submission and instill sponsors with confidence, clarity, and consistency across all clinical endeavors.
It is important to note that the FDA’s letter specifically reminded device firms of their responsibility to ensure that all information submitted to the FDA is truthful and accurate. The Premarket Notification Truthful And Accurate Statement required by 21 CFR 807.87(l) to accompany each premarket submission reinforces this call for increased diligence.
How Beaufort can help
As the FDA intensifies efforts to confront data integrity violations through initiatives like the BIMO, Beaufort emphasizes the importance of vigilance and preemptive measures throughout the clinical trial process.
We invite you to explore our Clinical Monitoring Oversight solutions to learn more about how we can help fortify the integrity of your trial data, improve regulatory compliance, and safeguard your medical device development.