FDA says efforts to monitor devices from China unhindered by coronavirus

The Food and Drug Administration (FDA) has said its efforts to monitor medical products from China are not being hindered despite its inability to conduct inspections in the country due to the coronavirus.

In a statement on the FDA website, the Agency says it has additional tools it is utilising to monitor the safety of products from the country and will continue to monitor the global drug supply chain by prioritising risk-based inspections in other parts of the world.

The statement read: “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 U.S. 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).  

“In response to the COVID-19 outbreak, the FDA will utilise, where appropriate, our authority to request records from firms “in advance or in lieu of” drug surveillance inspections in China. The Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act (FDASIA) of 2012, gives the FDA authority to request records “in advance of or in lieu of” on-site drug inspections.”

The FDA says it is not seeing the outbreak result in increased public health risk as a result of imported products but will continue to update guidance as and when it is necessary.