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.
Staffing support can be particularly valuable during critical operational moments. Regulatory inspections, ...
