The average American cannot help but fear the health implications of contracting the novel coronavirus. While the novel virus, according to experts, is here to stay, it is noteworthy that the Food and Drug Administration (FDA) has laid down the guidance that allows in vitro diagnostic tests in certified laboratories prior to the issuance of emergency use authorizations (EUA) for such diagnostics. This is considered a prompt move on the part of the FDA against the threats posed by the virus since a medical catastrophe was ascertained by the Secretary of Health and Human Services.
Statistics shows that the coronavirus disease (COVID-19) spreads faster than the dreaded swine flu in 2009. As with any outbreak, early detection of the virus and containment of COVID-19 become a protocol. This entails a systematic approach within the agencies concerned. The step taken by the FDA has been one proof which shows that the important goals are now in the works.
The recommendations for test developers is clearly the greatest impact of the FDA guidance. This policy will enable laboratories to use validated diagnostics before an FDA review. In this manner, tests will become more available across the states. A faster healthcare delivery system is ensured. Doctors and other healthcare practitioners are furtherly guided. More lives are saved when misdiagnoses and delays in management are prevented. Moreover, the containment of the epidemic will erase societal stigma and cease interruptions in daily operations.
Community spread is preventable. It matters a lot if an asymptomatic carrier of the virus is immediately tested rather than catching the virus late when it has already weakened a person’s immune system. Medical practitioners can only do so much depending on how a patient presents or manifests a disease.
The American people will directly benefit from the legitimate move made by the FDA. This should be a common ground. In the coming days, there will be changes on how citizens perceive the coronavirus. Slowly but surely, the utilization of more and newer tests for the coronavirus will open doors for optimism and pave the way for a better understanding of the virus that can be used to advance the quality of treatment and service.
Continued success of the FDA policy will materialize when there is proper implementation. This denotes cooperation from agencies that are directly concerned. Resources must be allocated to make sure that aims and purposes within the scope of every department are maintained.
The approach done by the FDA regarding the coronavirus has been pragmatic. The decision to allow the performance of tests that will detect the coronavirus prior to issuing emergency use authorizations means greater availability of the tests, and therefore a larger population can be diagnosed whether the carrier is in the active stage of the disease or not presenting symptoms. The FDA has certainly asserted its function of protecting public health.