BAD NEWS FOR ADTX: FDA Will No Longer Review EUA Submissions for SARS-CoV-2 Lab-Developed Tests
A caller from a high-complexity lab noted his group had submitted an LDT several months ago and recently submitted responses to FDA's feedback. That type of submission will now be declined, Stenzel said. "If you haven't received an EUA authorization already, then we will from here forward be declining to review any LDTs," he said.
Once the agency generates a list of pending LDT EUAs it will send a letter to developers to let them know, Stenzel said. "We are going through our submissions and determining which tests are LDTs, and they will get a letter as soon as we can get that out to them," he said.
A letter is coming!
