ASCA, CLAP, Fraudulent Biocompatibility Data and You

RAQA Today

Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Some unethical third-party testing labs are sending their clients data mined from old 510(k) submissions - and passing it off as fresh data. So what's a medical device manufacturer to do? That was the topic of conversation this month when I chatted with Mike McGrew and Sandi Schaible from WuXi AppTech.