Food and Drug Administration (FDA) is working extensively to prevent the possible consequences of the spread of Coronavirus (COVID-19) in relation to Medical Devices, with the use of a coordinated approach that provides for actions on several fronts for the maximum protection of public health.
FDA monitors constantly the product supply chain, including any interruption of supply or the Medical Devices potential shortage in the United States. Special consideration shall be given to important Medical Devices and that record a high demand in this period, such as the Personal Protective Equipment (PPE), as for example breathing apparatus, surgical gowns, gloves and masks.
In the event of Medical Devices potential shortage, FDA has all the required instruments to react promptly and to mitigate the impact on patients and on US health operators. Furthermore, in these cases, FDA transmits updating communications.
To minimize the COVID-19 impact, FDA works with the US Government and with the US Department of Health and Human Services, with the International counterparties, and it works closely with hundreds of human and animal medical device manufacturers and it is syncronized with the International Regulatory Authorities.
While the possibility to carry out inspections in China as a result of the Travel Advisory provisions of the U.S.A. State Department has been interrupted, FDA continues to carry out regular surveillance tests and the complete supervision of the imported products, included those coming from China.
The implemented surveillance procedures are a lot: instruments such as the screening of the importations based on the risk, sampling exams, notices of import, evaluation of the compliance history; finally, the information from foreign governments in compliance with the mutual recognition agreements are used.
It is important to remember that there are no evidence supporting the COVID-19 transmission linked to goods and there were no cases of COVID-19 in the United States linked to imported goods.
To protect manufacturers and consumers, FDA anti-fraud team monitors online products promoted to prevent or cure Coronavirus.
Coronavirus (COVID-19) trend spread is dynamic and the FDA will continue to assess and update the guide lines according to the needs.