HHS Directs FDA To Review Voluntary EUA Applications For COVID-19 LDTs

HHS has directed FDA to review emergency use authorization applications voluntarily submitted for COVID-19 laboratory-developed tests -- reviews that FDA told labs in October it would no longer conduct following HHS’ controversial August pronouncement that FDA lacked jurisdiction over LDTs . The August move put labs in a quandary because FDA authorization is required for them to get liability protection for the tests, now regulated by CMS, during the pandemic. HHS Assistant Secretary for Health Brett Giroir told reporters on...