While coronavirus is not yet widespread in the United States, the FDA is trying to keep it that way, both domestically and internationally. In a statement released last last week, the FDA summarized its mission.
The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts.2
To that end, the FDA is fulfilling its mission by:
- Keeping an eye on the medical device supply chain
- Inspecting imported products
- Ensuring the overall safety of consumer products
- Monitoring misleading or false claims at retail
- Preventing the spread of the disease
Let’s take a deeper dive.
Keeping an eye on supply
Apple isn’t the only company affected by supply chain woes. Medical device companies are not only constrained by raw material shortages for production, but also due to increased demand for their products.
The FDA is not simply waiting for shortages to be reported. They are actively reaching out to major manufacturers of human and animal medical devices to identify disruptions and shortages proactively, as well as coordinating with global regulators like the European Medicines Agency to ensure they’re in sync with international issues.
To monitor spikes in demand, the FDA is also tracking medical device distributers, especially those that deal with personal protective equipment like respirators or suits.
Ensuring imports are safe
While inspecting foreign products is “business as usual” for the FDA (medical devices) and the U.S Customs and Border Protection (CBP) (consumer goods), coronavirus has certainly heightened the urgency and is currently the highest priority of the agencies.
Medical Device Entry Process
The FDA has implemented an “agile” model to protect the American public. Agility allows the FDA to respond to new data and implement stricter control on a case-by-case basis, especially for high-risk medical products.
For now, high-risk products with misleading, false, or missing information are flagged for manual review. What is high risk exactly? Typically, it refers to the classification, meaning that Class I products are low-risk, and Class III products are high-risk. Additional requirements usually exist for devices that emit radiation.
The outbreak of coronavirus has made the FDA implement it’s risk-based approach to assessing medical device risk. This includes historical quality standards and manufacturing volumes.
Additionally, the FDA is not conducting inspections in China due to the State Department Travel Warning.
To simplify the process, the FDA provides a database that allows manufacturers to identify the classification of a medical device.
Furthermore, depending on the device, affirmation of compliance codes can further clarify how a product meets requirements, such as component identifiers, device listing number, or device impact resistance lens certification. This can speed the FDA’s initial screening and prevent flags that send a product to manual review.
All consumer items that enter the United States are required to comply with regulatatory requirements established by the CBD. Like medical devices, high-risk products with misleading, false, or missing information are flagged for manual review.
Fortunately, there is no indication that coronavirus transmission has ever been associated with imported goods.
Oregano oil, immune boosters, grifters
Oregano oil, immune boosters, vitamin C, spicy food cure-alls? Misinformation abounds in an environment where tragedy attracts con-artists, and the FDA is cracking down on products that claim to prevent, treat, or cure coronavirus.
To fight misleading claims, the FDA has created a cross-agency task force that monitors misleading claims, with the assistance of major retailers. Dozens of products have already been removed, and several large players – like Facebook – are self-policing.
In a statement, the social media giant stated:
Our global network of third-party fact-checkers are continuing their work reviewing content and debunking false claims that are spreading related to the coronavirus. When they rate information as false, we limit its spread on Facebook and Instagram and show people accurate information from these partners. We also send notifications to people who already shared or are trying to share this content to alert them that it’s been fact-checked.3
Diagnose, treat, prevent
In addition to ensuring the safety of medical devices, the FDA is also committed to ensuring the products needed to diagnose, treat, and prevent coronavirus are available to the public. This commitment includes guidance, technical assistance, and regulatory advice.
As a result of this push, the CDC developed a diagnostic test to detect coronavirus. To expedite its use, they submitted an Emergency Use Authorization to the FDA, which allows unapproved products to be used during a public health emergency. In coordination with International Reagent Resource, test kits have been shipped to the World Health Organization and Influenza Surveillance Response System.
If anything, this shows that the FDA is not afraid to expedite in a crisis.
For medical device companies, consider these key takeaways from the FDA’s statement:
- Ensure your medical device’s registration and listing are correct, and verify all requirements are met
- Absolutely do not make false or misleading claims
- Reach out to the FDA when you need assistance
We’ll have more information as news breaks.