The FDA’s Response to COVID-19

by | Jun 12, 2020 | COVID-19, FDA

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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Madison Green

Madison Green

Director of Technical Operations - Mrs. Green 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. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green 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.

More Resources

Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

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