Recent 510(k) Clearances for Devices Imported from China

#1
As a part of a supply chain business risk assessment, we are looking for regulatory intelligence on the recent experience of Chinese companies selling medical devices in the United States in relation to FDA premarket clearance.

While US Chinese relationships have soured generally, we are interested in the current relationship between FDA and Chinese medical device accessory suppliers. There were many Chinese products in both the personal protective equipment and diagnostic testing realm that did not meet FDA standards that were nonetheless being imported into the US. FDA undertook a major enforcement initiative to stop violative products from China entering the US. For example, FDA published a notice warning healthcare professionals about Chinese masks. The agency also issued a couple of import alerts that included Chinese medical devices including Import Alert 89-08 and Import Alert 89-04.

We are interested in whether those enforcement actions have spilled over into the premarket clearance process at FDA, causing FDA now to be more demanding than they were before the pandemic with regard to the evidence required to support a 510(k). The products of interest are things like ECG and EKG cables, SPO2 sensors, and NIBP accessories. While these products are relatively simple and straightforward, because they are accessories to other medical devices, as those other medical devices change, these accessories must likewise change to keep up. Those changes will sometimes trigger the need for a new 510(k). We are interested in whether going forward, FDA will be more demanding with regard to 510 K submitted by Chinese companies, potentially even rejecting the submissions.

There are numerous Chinese companies that supply these products. This is not focused on any one company.

Has anyone heard whether FDA is being more demanding recently in reviewing 510(k)s for Chinese companies?
 
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#2
I do not think this will come under the purview of the FDA. Most likely under commerce or trade department, meaning FDA will do what it does, clear the 510(k), but for some other reason, you can't clear customs import. We had some issues with customs clearance in Asia due to labelling issues, but these were not related to the registering of the device. So, I wouldn't be worried about politics with the FDA. Not sure what others think.
 
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