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...
Jeff Shuren, director of the US FDA’s device center, says the agency is drafting a guidance document that will give industry recommendations on how it should handle products granted emergency use authorization during the COVID-19 public health emergency, once it’s over. The guidance will also address already-approved devices that were modified by their makers under enforcement discretion.
Yes, Gottlieb’s in there twice; things get complicated when an agency starts to lose credibility.
CDRH director Jeff Shuren says the US agency’s device center has been tallying up lessons learned from the COVID-19 pandemic.