While the FDA is unable to conduct inspections, it plans to rely on tools such as import screening, examinations, sampling and import alerts, along with information from foreign governments, to monitor FDA-regulated products that enter the country.
When the advisory is changed, the FDA intends to resume routine inspections as soon as possible.
According to the statement, more than 60% of FDA-regulated products imported from China are medical devices, with a further 20% coming in the form of housewares, such as food packaging.
The FDA also said it plans to exercise its authority to request records from firms in advance or in lieu of drug surveillance inspections in China, allowing the agency to review records ahead of time and take a risk-based approach in conducting domestic and foreign inspections. The FDA said it hopes this will help it assess the potentially backlogged number of on-the-ground surveillance inspections in 2020 if the travel restrictions continue.
On top of that, the FDA said it intends to continue working with U.S. Customs & Border Protection to target products meant for importation into the U.S. that may violate legal requirements for FDA-regulated products.
“We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as international mail facilities,” the FDA wrote in the statement. “We can refuse admission of products that fail sample testing or may violate other applicable legal requirements.”
As of right now, the FDA has not seen the coronavirus outbreak cause an increased public health risk for American consumers using imported products. No evidence supports the transmission of the disease from imported goods, although the FDA said it remains a dynamic situation.
“We assure you that the FDA is working around the clock to monitor and mitigate emerging coronavirus issues through collaborative efforts with U.S. regulators, international partners, and medical product developers and manufacturers to help advance response efforts to combat the COVID-19 outbreak,” the agency wrote.
Mark Bonifacio, who owns Bonifacio Consulting Services, which entered into an alliance with Fujitech to form MedAsia Manufacturing in Shanghai, said the biggest concern with coronavirus in China centers around the ability to get production running at full pelt again.
Because of established supply chains and the FDA’s arsenal of tools for monitoring China, Bonifacio believes the lack of on-the-ground inspections for the time being shouldn’t be too much of a concern at all.
“Because this is a longstanding supply chain, the FDA has a lot of other tools at their disposal that they’ve always really used when monitoring China, because it’s hard to get field agents out there to begin with,” Bonifacio told MassDevice. “Especially for larger OEMs, they have really well-developed supply chains. … A lot of the medtech products made in China are longstanding and haven’t had a lot of changes, so those kinds of things will almost be invisible to what’s happened here.”
