FDA Issues Reminder for Medical Device Manufacturers to Ensure Data Reliability

The U.S. Food and Drug Administration (FDA or agency) recently issued a reminder to medical device manufacturers and sponsors regarding the use of third-party-generated data in their premarket submissions. On February 20, 2024, the FDA wrote that manufacturers and sponsors must, “carefully evaluate the third parties they engage to conduct performance testing and . . . independently verify all testing results before submitting to the FDA.”

An Emerging Trend of Unreliable Data in Premarket Submissions

The FDA’s reminder follows what the agency describes as a years-long trend of manufacturers and sponsors increasingly submitting data from third-party testing labs, “that are fabricated, duplicated from other device submissions, or otherwise unreliable.” As the FDA goes on to explain:

“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.”

In its advisory, the FDA makes clear that manufacturers and sponsors have an affirmative obligation to ensure the accuracy of all data they submit. While reminding manufacturers and sponsors of this obligation, the FDA also notes that it has begun taking “various actions” to assess the integrity of data included with premarket submissions. This includes actions taken under the FDA’s Bioresearch Monitoring Program (BIMO), which the agency describes as, “a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research,” that conducts more than 1,000 inspections annually.

The FDA’s Expectations of Medical Device Manufacturers and Sponsors

The FDA notes particular concerns with third-party testing labs in China and India, although it also makes clear that issues of data reliability are not limited to labs in these countries. To ensure that they are not including unreliable data in their premarket submissions, the FDA advises that medical device manufacturers and sponsors take steps such as:

• Scrutinizing test results that, “are improbable or impossible on their face;”

• Carefully examining data that, “do not seem consistent with known information about [a] device;” and,

• Not solely relying on a lab’s accreditation (with the FDA stating that, while it encourages manufacturers and sponsors to partner with labs accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program, this “does not substitute for conducting an independent assessment of all third-party data”).

As the FDA will not approve submissions based on unreliable data, it is imperative that manufacturers and sponsors heed the agency's advice and ensure that they are taking all necessary steps to confirm the accuracy of their submissions. Not only is this important for FDA compliance, but it is important for avoiding scrutiny from other federal authorities and mitigating companies’ civil litigation risk as well.

Conclusion

At Gardner Law, we assist medical device manufacturers and sponsors with conducting third-party data reviews. We also proactively engage with the FDA on behalf of our clients during the premarket review process and when issues arise. Having a submission rejected by FDA due to bad data not only derails your immediate plans, but it can impact the entire project. Scrutinizing all aspects of a regulatory submission should be standard industry practice. For assistance with this topic contact Gardner Law.