FDA & the Coronavirus (COVID-19) Pandemic

by | Mar 13, 2020 | Coronavirus, FDA, Shortage

Amid the COVID 19 pandemic, with 10 states in the US declaring a ‘state of emergency’, foreign and international travel restrictions, FDA released a series of advisories and statements to keep the public informed of the situation. The FDA is working with U.S. government partners including the Centers for Disease Control and Prevention (CDC), medical product manufacturers, and international partners to control the situation surrounding the COVID 19 outbreak.1

The FDA released a statement on March 10th, 2020 that FDA inspections outside of the U.S will be postponed through April. International inspections deemed mission-critical will still be considered on a case-by-case basis. FDA also stated that when physical inspections of foreign-produced products are not possible, additional measures are put in place such as denying entry into the US for unsafe products, product sampling at US borders, reviewing a firm’s previous compliance history with the FDA and other regulatory agencies when such information is available.2

On the other hand, Private labs are facing delays in getting clearance because of the FDA. Some private laboratories have either developed new test methods to test COVID-19 or they already have the equipment that can test the new virus. The problem with using the existing equipment is that they weren’t cleared for testing coronavirus as its original intended use of the product and should be approved for this change. These labs are waiting on getting expedited product clearance from the FDA.3

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies who were trying to sell unapproved drugs to prevent or treat the novel coronavirus and requesting companies to respond in 48 hours to the warning letter. The FDA is particularly concerned that the products that claim to cure, treat or prevent COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm.4

We are closely monitoring the situation and will keep you informed on all of FDA’s efforts. If you are looking to get your device on the market to help diagnose, treat or prevent COVID-19, give us a call at 248-987-4497 or email info@emmainternational.com.

1FDA (March 2020) Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions retrieved on 3/12/2020 from https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19-frequently-asked-questions

2FDA (March 2020) Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections retrieved on 3/12/2020 from https://www.fda.gov/news-events/press-announcements/coronavirus-disease-2019-covid-19-update-foreign-inspections.

3NBC News (March 2020) Many private labs want to do coronavirus tests. But they’re still facing obstacles and delays retrieved on 3/12/2020 from https://www.nbcnews.com/health/health-care/many-private-labs-want-do-coronavirus-tests-they-re-facing-n1156006

4FDA (March 2020) Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19 retrieved on 3/12/2020 from https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-and-ftc-warn-seven-companies-selling-fraudulent-products-claim-treat-or

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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.

Ready to learn more about working with us?

Pin It on Pinterest

Share This