Biocompatibility and Fraudulent Data in the Age of AI

With the advent of AI, there has been a spike in the amount of fraudulent data submitted to the FDA. Some unethical testing labs are simply mining 510(k) data from the 1990s and passing it off as fresh data - leaving manufacturers scrambling.
In this conversation with Mike McGrew and Sandi Schaible from Wuxi, we discuss what manufacturers can do to ensure that they don't get caught up in this scam.
Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501 medical device regulation, FDA 510(k), medical device classification, FDA 510k clearance, regulatory affairs, FDA 510k approvals, regulatory affairs medical devices, FDA pre submission, regulatory compliance, FDA submission, FDA 510k submission guidance, biocompatibility