A recent communication from the FDA has reported a trend of an increasing amount of fraudulent data related to medical device testing from third-party labs. The FDA’s communication not only reiterated the responsibility of equipment manufacturers to validate third-party test data, but also highlighted the potential risk to hospitals that equipment they are using or planning to purchase may become unavailable for these reasons.
Relevant highlights from the FDA’s announcement:
– A growing volume of unreliable and fraudulent data is being used by third-party labs that provide performance testing for medical device manufacturers, specifically in China and India.
– This could have an impact on hospitals and patient care and reduce availability of new medical devices, further disrupting hospital supply chain needs for critical technology. Devices awaiting approval might not get approval, and others already approved risk being recalled if the FDA finds questionable data were used as a basis for approval.
– The FDA is asking device firms to be proactive and heavily scrutinize third-party test labs, as well as any research and data that is not directly overseen or generated themselves.
See the full FDA communication.
This is another example of how critical having the best information is for hospitals. Miga will continue to monitor and share information on this topic as it becomes available. If you have questions or would like to learn more about how you can continue to get the best information about the medical equipment lifecycle, please reach out. We look forward to hearing from you.