COVID-19 Medical Supplies Shortage

by | Mar 6, 2020 | Coronavirus, FDA, Medical Devices, Requirements, Shortage

As the spread of the 2019 Coronavirus Disease (COVID-19) continues to grow globally, the FDA and other global health organizations have had to put precautions in place to protect the public. With over 93,000 confirmed cases world-wide, a global shortage of crucial medical devices has forced the FDA to authorize additional EUA’s (which you can learn about in our blog post here).1 Specifically, there is a shortage of respirators that are used by healthcare workers to prevent exposure to pathogenic airborne particles.

The FDA currently regulates N95 Respirators as class II medical devices.2 They are common devices found across healthcare centers nationally, but with the onset of COVID-19, there has been an increased demand that manufacturers can’t keep up with. Considering that these devices are critical to protect both healthcare personnel and the general population from the continued spread of disease, on March 2nd, the FDA and the CDC issued an EUA for all disposable filtering facepiece respirators (FFR’s) that are approved by the National Institute for Occupational Safety and Health (NIOS). The EUA also grants authorization to use FFR’s that were NIOSH approved but have passed the manufacturer’s recommended shelf life.3 While these respirators are normally not authorized for use in healthcare settings, the FDA recognized the necessity of granting the EUA to protect healthcare workers. This authorization is intended to maximize the number of respirators and hopefully meet the current demand of the health care system.

Unfortunately, a shortage of additional medical supplies is on the horizon in light of the COVID-19 spread. On Tuesday, the World Health Organization (WHO) Director, Dr. Tedros Adhanom Ghebreyesus, stated that the WHO estimates that 89 million medical masks, 76 million examination gloves, and 1.6 million goggles will be required for an adequate response to the outbreak.4 The organization fears that the rapidly declining supplies of critical medical devices will leave healthcare personnel vulnerable and continue to ignite the spread of the disease. The organization is working with governments and manufacturers to try to boost production. It is predicted that the global supply will need to increase by at least 40% in order to meet demand.5

If you are looking to get your device on the global market to support the ongoing healthcare activities surrounding COVID-19, EMMA International has the expertise to assist. Give us a call at 248-987-4497 or email info@emmainternational.com to see how we can help.


1WHO (March 2020) COVID-19 Situation Dashboard retrieved on 03/03/2020 from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019

2FDA (March 2020) Product Classification Database retrieved on 03/03/2020 from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=ONT

3FDA (March 2020) Emergency Use Authorizations retrieved on 03/03/2020 from: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

4Berlinger, CNN (March 2020) WHO warns of global medical equipment shortage as world braces for coronavirus spread retrieved on 03/04/2020 from: https://www.cnn.com/2020/03/04/asia/novel-coronavirus-covid-19-intl-hnk/index.html

5Nedelman, YU (February 2020) Health Care Braces for Shortages of Supplies due to Coronavirus retrieved on 03/04/2020 from: https://www.cnn.com/2020/02/29/health/fda-medical-device-mask-hospital-shortage/index.html

Madison Wheeler

Madison Wheeler

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.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

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.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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