Warning Letter Roundup & Recap – 16 September 2020
Two companies were sent FDA warning letters for selling adulterated COVID-19 tests, while a third was dinged for selling its transilluminator device for breast evaluation without agency approval or clearance.
You may also be interested in...
The US agency has announced four more webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.
The US FDA’s list of essential products for use during infectious diseases outbreaks and other public health threats comes almost three months after President Trump signed an executive order directing the agency to develop one.
The US agency is giving manufacturers of automated external defibrillator accessories roughly 15 more months to comply with a 2015 final order that requires them to file premarket submissions with the agency.