Regulatory Open Forum

Hi all, 

I would appreciate your thoughts on this.

We are a foreign manufacturer of a US class II device (with 510K clearance). The device is to be used with an accessory manufactued by a different company, and by its own, it's also a medical device, class II, with 510(k) clearance. Both are manufactured outside of the US, so my question is: for importing the accessory into the US, do I need to reference the original accessory's 510K clearance and only use their established importers?, 

OR,

since I included that accessory in the main device 510(k) as an accessory (referencing its own 510K, but providing the specific measurements that are specific to be compatible with this specific device, with its own V&V, catalog number and label), can I use the main device 510(k) and the main device importers for importing the accessory?

I've never dealt with import/export issues, so any guidance and FDA regs on this would be helpful, I havent found anything on this yet.

Thanks, 

A

I like to refer to the following FDA website links for reminders about the medical device import process:

https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-and-radiation-emitting-electronic-products-us#process

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

When entering the 510(k) information (among other associated information) into the import brokering documents and importation systems, I would tend to choose the 510(k) that will most directly align with the information on the label / package of the imported item.  In other words, an apparent deficiency can be perceived by FDA's import reviewers if the accessory device is just mentioned/buried in the parent device 510(k) and the parent device 510(k) doesn't in its 510(k) name or FDA's 510(k) database or other internal databases clearly identify the accessory and its own respective 510(k), thus causing FDA's import reviewers to think that there's no 510(k) for the accessory and that your citation of the parent device 510(k) is an erroneous 510(k).

So, based on my prior experiences with import holds, I would make it as easy as possible for the import reviewers to make the connection between the device they're looking at in hand at customs compared to the information in their resource database(s). If I could enter both 510(k) numbers, then I'd do that, with the accessory's own 510(k) listed first.  If I could only choose one, then I'd probably go with the accessory device's own 510(k) presuming the accessory is labeled in its own right.  If on the other hand, the accessory's labeling reflects it as a part of the parent device system, then that could push the decision back toward identifying the parent device 510(k).  It will all depend on what the importer reviewers are seeing on the accessory device label/package in these respects.

The U.S. initial importer of the device unit(s) / shipment(s) must be FDA-registered as such an entity for importation from the specific manufacturer whose devices are being imported.  So be sure to use the importer(s) that have so registered for importation of devices from those particular foreign manufacturers.  If both parties' (the parent device manufacturer's and the accessory manufacturer's) importers are so registered, then either could be used.  But only one importer can be used/identified for each particular device importation/shipment; specifically, the importer that is doing the importation for that particular device importation/shipment.  In other words, there could be multiple registered importers for a foreign manufacturer's devices/accessories, and the manufacturer can in general choose to have a given importation done by any of those properly registered initial importers.  But as a general rule, there shouldn't be multiple initial importers listed/identified for a given particular importation/shipment.  Maybe there could be an exception to that if the importation/shipment has somehow been divided into parts whereby one initial importer is importing one part of the shipment, and a different initial importer is importing a different part of the shipment. But I wouldn't recommend that, as FDA's import and import review process can be quite finicky.

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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