Earlier this year, U.S. regulators cautioned medical device manufacturers regarding the accuracy of data submitted by third-party testing laboratories. The regulators brought attention to concerning reports of falsified and unreliable data from some labs, many of which are in China and India. In the communication, regulators stressed the importance of device firms taking proactive measures to qualify third-party test labs and rigorously evaluate all testing data, particularly for biocompatibility and other performance testing, included in a submission to the FDA.
According to the statement, regulators have found an increasing number of instances of third-party test labs “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.”
WuXi AppTec experts Sandi Schaible and Mike McGrew joined Michelle Lott on her leanRAQA podcast to discuss the announcement and give device manufacturers five key takeaways, including:
1. Use ASCA-accredited laboratories to ensure data integrity
2. The CLAP program could help, but it’s still too early to know
3. Do your diligence when selecting a lab partner
4. Take advantage of the pre-submission process
5. Insist on collaboration & complete chemical characterization
The bottom line
This recent regulatory warning highlights the critical need for careful data verification and the importance of working with trusted lab partners. This helps manufacturers ensure the integrity of the data submitted and provides a smoother path to market clearance or approval. Together, these measures safeguard medical devices and support patient safety.
