In a newsletter dated February 20th, the Food and Drug Administration (FDA) sounded an alarm regarding the proliferation of fraudulent and unreliable laboratory testing data in premarket submissions. This warning comes in response to an alarming increase in instances where submitted data have been found to be „fabricated, duplicated from other device submissions, or otherwise unreliable“. Consequently, affected data have been rejected, and the corresponding medical products have not received approval.
This revelation underscores the critical importance of maintaining data integrity throughout the medical device approval process. The FDA is calling upon all manufacturers to take proactive measures to prevent such incidents, particularly concerning data related to biocompatibility and other performance testing. To achieve this, the FDA recommends several key actions:
- Qualify third-party test laboratories: Manufacturers should thoroughly vet and qualify third-party test laboratories to ensure their credibility and adherence to rigorous standards.
- Closely scrutinize external testing data: Manufacturers must carefully scrutinize all testing data that they did not conduct themselves. Any inconsistencies or anomalies should be thoroughly investigated to maintain the integrity of the submission.
- Identify improbable or inconsistent results: Manufacturers should be vigilant in identifying testing results that appear improbable or inconsistent with known information about the device. Any discrepancies should be addressed and clarified before submission.
Recommended Actions
In addition to these measures, the FDA is advocating for additional steps to enhance data integrity in medical device submissions:
- Collaborate with accredited laboratories: The FDA encourages collaboration with laboratories accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program. Working with accredited laboratories can provide assurance of adherence to recognized standards and protocols.
- Bioresearch monitoring program: The FDA is actively pursuing various actions through third program to identify and address data integrity violations. It includes on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research.
- Vigilance and proactivity: FDA urges the entire medical device industry to remain vigilant and proactive in ensuring the integrity of all data included in submissions. By prioritizing data integrity, manufacturers can uphold the highest standards of safety and efficacy in medical devices.
How can Qserve assist you?
As a company dedicated to upholding the highest standards of quality and regulatory compliance, Qserve wholeheartedly support the FDA's call to action. We urge our customers to prioritize the thorough evaluation of contracted work, data and reports supplied by both new and existing contract laboratories. In an environment where data integrity is paramount, diligent scrutiny is essential to safeguarding the integrity of medical products.
To assist our customers in this endeavour, we recommend a series of checks and measures to uphold data integrity:
- Quality Assurance Agreement: Ensure the existence of a valid quality assurance agreement between your company and third-party test laboratories. This agreement sets the foundation for clear expectations and accountability. It should also include the following measures.
- Review of certifications: Carefully review ISO 17025 and GLP certificates of laboratories, including scopes and validity. These certifications serve as indicators of a laboratory's competence and adherence to established standards.
- Protocol compliance: Review protocols and confirm compliance with applicable standards or guidelines. Ensure that versions of standards or guidelines are up to date.
- Audits: Conduct audits during the testing phase and verify e.g., the qualifications of the study director and staff involved. Check data recordings against Good Documentation Practices (GDP) rules and appropriate test environment conditions.
- Review of report: Scrutinize report contents, calculations, and interpretations. Ensure compliance with standards or guidelines as stated in the protocol, the completeness of the information and the alignment between results tables and raw data but also verify the accuracy of data processing.
- Second-level laboratories: When second-level contract laboratories are involved, inquire about related supplier management activities and data quality assurance agreements in place.
- Deviations and justifications: Investigate deviations from test protocols and assess their plausibility and justification. Transparency and accountability are key in addressing deviations effectively.
- Software validation: Verify the up-to-date status and validation of data processing software. Ensure that staff are adequately trained in its use.
- Standard Operating Procedures: Confirm the adherence to SOPs outlined in protocols and reports. Randomly select SOPs for review to ensure accuracy during test procedures.
At the heart of the medical device industry lies a commitment to safety, efficacy, and trust. FDA's warning serves as a reminder of the importance of data integrity in the medical device regulatory process and calls manufacturers to remain vigilant in ensuring the accuracy and reliability of data submitted by third-party laboratories. Manufacturers must consider this call to action by implementing robust measures to safeguard the accuracy and reliability of their data submissions. By diligently implementing the above-mentioned measures, manufacturers can strengthen collaboration with third-party test laboratories and uphold the integrity and quality of data and reports. In doing so, manufacturers reaffirm their commitment to patient safety and regulatory compliance in the medical device industry.
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