Guidelines for Verifying Laboratory Testing Data Before FDA Submission

FDA’s Response to Data Integrity Issues

The FDA recently expressed concern regarding the rise of fraudulent and unreliable laboratory testing data in premarket submissions. The agency has identified a growing issue with the integrity of submitted data, observing instances where medical device manufacturers have submitted fabricated or duplicated laboratory testing data. Notably, these occurrences have been observed in labs based in China and India.

The submission of unreliable data has led to delays or rejections in device approvals, as the FDA cannot rely on such data for market access decisions. Consequently, patients and healthcare organizations need access to many new medical devices.

Proactive Measures for Data Integrity

To address these challenges, the FDA is taking proactive measures to identify and confront data integrity issues, ensuring that U.S. patients have access to safe and high-quality medical devices. The agency also encourages medical device manufacturers to play their part by exercising vigilance and verifying the integrity of the data they submit.

Best Practices for Ensuring Reliable Laboratory Testing Data

In light of the FDA’s warning regarding fraudulent lab testing data, medical device manufacturers must thoroughly assess the third-party entities they engage for performance testing. Additionally, manufacturers should independently verify all testing results before submitting them to the FDA.

Tips on Verifying Laboratory Testing Data:

Examine Sources, Methods, and Standards

Evaluate the data sources, methods, and standards providers use. Request samples or trials to assess quality and ensure compliance with regulations.

Define Data Criteria

Clearly outline your expectations and requirements to the provider to ensure that the data meets your needs.

Validate Your Data

Even with a reputable provider and defined criteria, validate and clean the data to ensure correctness, completeness, and consistency. Utilize tools or services for validation and cleaning, or perform these tasks manually.

Certify Lab Testing Facility

When selecting a third party to perform laboratory testing, ensure that such a facility has proper quality systems backed by FDA registration and/or ISO certification. Having FDA registration doesn’t guarantee recent inspections, whereas ISO certification entails yearly audits of your quality system.

Rook Quality Systems offers assistance in reviewing your laboratory data and detecting falsified data. Contact us today to learn more about verifying your lab-tested data!