The FDA’s Response to COVID-19
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.
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Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.