The FDA announcement (here) of its activities involved in expediting diagnostic tests for the Corona Virus (COVID 19) explains the actions that FDA has taken in response to this public health emergency.
“The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.” As FDA notes later in its release, tests that can produce false negatives could hasten the spread of COVID 19 and thus it is essential that the Agency knows that the proposed test works with a high degree of accuracy in detecting the virus.
The notice discusses the process for test development and also indicates “that more than 230 test developers are expected to submit requests for emergency authorizations” and notes that, as of the date of this announcement (3/30/20), 20 authorizations have been granted, along with 110 labs notifying FDA they have begun using their own tests.
FDA says that, with the Emergency Use Authorization, which has been put in place by Congress, they can perform the review of the tests and make authorization for use “in as little as one day, which it has done repeatedly”. The document also has a section on certain FDA policy updates and actions and “[I]n addition, the FDA implemented another change to empower states to take responsibility for tests developed and used by laboratories in their states without FDA review.”
FDA continues to work tirelessly to support the national attack on COVID 19 and its effort hopefully will lessen the impact on public health outcomes and help reduce the spread of this virus.
