Lab Owner, Test Kit Vendors Charged In COVID-19 Fraud Crackdown
The US Department of Justice has filed criminal charges against 18 individuals said to be responsible for a total of $490m in COVID-19 fraud, including several device- and diagnostic-related cases.
You may also be interested in...
The US agency is warning manufacturers about an alarming device submission trend toward unreliable data generated by third-party labs.
News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.
A year after Congress officially gave the FDA the power to ban devices for a specific use, the school that inspired the new law is taking the agency back to court on allegations it has failed to respond to document requests.