COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, was officially declared a pandemic back in early March. Since then the medical device industry has been trying to adjust to the far-reaching obstacles presented by this public health emergency, such as global supply chain shortages, social distancing risks, and more. As such, the FDA has also had to make significant and unprecedented changes to mitigate risks and make sure that public safety is continuously protected. In this paper, we will explore the FDA’s response to COVID-19 cohesively, looking at how the agency has had to modify some of its processes and policies, relax regulatory requirements, and what the future of the regulatory-landscape looks like for the medical device industry post-COVID-19.
There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
