FDA has issued exceptional emergency use authorisations (EUA) to ensure that patients and healthcare professionals have timely and continuous access to Medical Devices used to diagnose, prevent and treat COVID-19.
Below, it is shown how FDA authorizes the use of these devices through FDA EUA authorisations.
FDA EUA authorisations for two types of COVID-19 tests: diagnostic and antibodies
In vitro diagnostic tests are carried out on samples taken from human body to detect diseases and monitor a person’s general health. On February 4, 2020, the Secretary of Health and Human Services (HHS) ruled that, due to the ongoing health emergency, the use of in vitro diagnostics for the detection and/or diagnosis of the new COVID-19 is authorized.
In the United States a wide availability of tests is required to be able to control the emergence of this disease quickly. For this reason, FDA authorized two different types of tests: diagnostic and antibodies. As indicated in the “Policy for Coronavirus Disease-2019 Tests” document, these tests must be validated by the developer before they are offered for clinical use. FDA has issued over 100 EUA authorizations to allow the use of such tests during the COVID-19 emergency.
FDA EUA authorizations for medical equipment and PPE
Given the extreme need for ventilators to control or assist the patient’s breathing, FDA issued a EUA that authorizes the use of certain ventilators and accessories for the treatmentof patients with COVID-19.
As regards personal protective equipment (PPE), which includes gloves, surgical masks, respirators and other devices, FDA has established regulations on quality systems as well as good manufacturing practices to ensure that they are safe and effective. Moreover, FDA has published conservation strategies for use by health organisations and staff.
FDA has also issued EUA approvals for respiratory and for systemsthat can decontaminate certain types of N95 respiratory for re-use by hospital staff in a healthcare environment.
Other actions implemented by FDA in response to COVID-19
In order to protect public health during the pandemic caused by COVID-19, FDA has implemented other actions, such as: active monitoring for the supply of health and food products and the measures taken to stop the sale of fraudulent products.
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