Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak: COVID-19. We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat, and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity as we oversee the safety and quality of FDA-regulated products for American patients and consumers.
Today, we are providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by this outbreak. While we are not able to conduct inspections in China right now, this is not hindering our efforts to monitor medical products and food safety. We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue monitoring the global drug supply chain by prioritizing risk-based inspections in other parts of the world. The FDA is not currently conducting inspections in China in response to the US Department of State’s Travel Advisory to not travel to China due to the novel coronavirus outbreak. We will continue to closely monitor the situation in China so that, when the travel advisory is changed, we will be prepared to resume routine inspections as soon as feasible.
We already use other tools to help complement our inspections, including import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and we use information from foreign governments as part of mutual recognition agreements. Thus, at this time, we can rely on these other tools to give us comprehensive oversight of FDA-regulated products entering this country. This is all part of our agency’s risk-based approach to ensuring quality, as well as compliance with applicable FDA requirements.
It is important to reiterate that inspections are one of many tools that the agency uses to inform our risk strategy for imported FDA-regulated products and to help prevent products that do not meet the FDA’s standards from entering the US market. A wide variety of FDA-regulated products are imported from China, which makes it important to assure the public of the quality of these products. At this time, over 60% of FDA-regulated products imported from China are medical devices and 20% are housewares (like food packaging).
