The FDA has issued a reminder to medical device manufacturers and sponsors about the critical importance of evaluating third-party laboratories conducting performance testing. This notice, dated February 20, 2024, highlights the responsibility of manufacturers to ensure that the data they submit to the FDA is both truthful and accurate.
Recently, the FDA has noticed an increase in unreliable data from third-party labs, including cases of fabricated or duplicated data. This issue is particularly prevalent with labs based in China and India. Such unreliable data compromises the FDA’s ability to authorize marketing for medical devices, impacting the manufacturers, healthcare providers, and patients due to reduced access to new devices and potential supply chain disruptions.
The FDA urges device firms to rigorously qualify third-party test labs and scrutinize all testing data, particularly in areas like biocompatibility and performance testing. While the Accreditation Scheme for Conformity Assessment (ASCA) program is recommended, it does not replace the need for independent assessment of third-party data. The FDA emphasizes that manufacturers should be able to identify improbable or inconsistent testing results.
To safeguard patients and healthcare providers, the FDA is taking actions through its Bioresearch Monitoring Program to address data integrity violations. Additionally, the agency is calling on the medical device industry to be proactive in ensuring the integrity of data in submissions, to maintain the safety and quality of medical devices available to U.S. patients.