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
