Category: FDA Fraud

Study Shows Whistleblowers Help Curb Fraud

According to a study by Jaron H. Wilde at the University of Iowa (an assistant professor of accounting in the Tippie College of Business), whistleblowers...

FCA Liability Awaits Medical Device Companies That Submit False 510(k) Notices to Avoid Class III Premarket Approval Process

Increasingly, the United State Department of Justice is cracking down on medical device makers who fraudulently obtain FDA clearance for their products. DOJ is particularly...

Medical Device Manufacturers Marketing Pre-1976 Devices for Unapproved Uses

In 1976, Congress amended the FDCA to require any post-1976 devices to be approved via the rigorous Pre-Market Approval (PMA) process, unless the manufacturer could...

Unapproved At-Home Genetic Tests Might Run Afoul of the FCA and the FDCA

Recently, the Food and Drug Administration ordered genetic-testing company 23andMe Inc. to stop marketing its mail-order genetic testing kit, citing the risk that false results...

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