Importing Material before the 510(k) is Approved

[markvm68]

We have a sister company outside the US that is filing for a 510(k) for a class II device. We distribute their product here in the US. The question has been asked, "Can we bring the product into the country and hold it at our facility until they receive 510(k) approval"?

My answer was no. That the material would be held up in custom's until the 510(k) was approved as it wouldn't be an approved medical device.

I thought I'd ask to see if anyone else has any experience in this area as we can't be the first company to want to do this.

Any input is greatly appreciated.

Mark

 

[MIREGMGR]

Is it possible to bring the product into the US in subassembly/component form, fully completed except for medical device labeling?

Of course the eventual labeling operation would have to be controlled and would have regulatory manufacturing-location implications, and might not be consistent with what's being declared in the 510(k) application.

I don't know of another way to do what's desired without breaking rules.

 

[markvm68]

No. We couldn't bring it in and assemble it as "it" is the device itself.

Thanks for the quick feedback.

Mark

 

[bio_subbu]

Dear Mark

It’s not possible to import the device until it has complied with all applicable US device regulations. Please check the link “overview of device regulations”

The device needs a cleared 510(k) in order to be imported into the U.S. When importing devices, the paperwork for Customs should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations.

 

[Pads38]

From the overview link posted above:-

............you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so.

What you cannot do is distribute the device. You can import it. But without a 510(k) clearance it can be a problem getting through customs.

 

[bio_subbu]

From the overview link posted above:-

What you cannot do is distribute the device. You can import it. But without a 510(k) clearance it can be a problem getting through customs.

Medical devices that are imported into the U.S. must meet “Bureau of Customs and Border Protection” (CBP) requirements in addition to FDA. Product that does not meet FDA regulatory requirements may be detained upon entry. When importing devices, the paperwork for customs should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. The product information should include, the “device name, product code, importer registration number, foreign establishment registration number and name of their U.S. agent, medical device listing number, Premarket Notification 510(k) or Premarket Approval number, if applicable.

In case if the product exempt from premarket notification, you have to mention the specific product regulation which exempts the device from 510(k).

Please refer below link on the import process
https://www.fda.gov/MedicalDevices/...tingandExportingDevices/ucm050126.htm#process

 

[YellowQCPro]

We have a sister company outside the US that is filing for a 510(k) for a class II device. We distribute their product here in the US. The question has been asked, "Can we bring the product into the country and hold it at our facility until they receive 510(k) approval"?

My answer was no. That the material would be held up in custom's until the 510(k) was approved as it wouldn't be an approved medical device.

I thought I'd ask to see if anyone else has any experience in this area as we can't be the first company to want to do this.

Any input is greatly appreciated.

Mark

Hi Mark,

I know it's been years since your original post, but I'm wondering if you recall the success of your above approach to importing material ahead of the 510(k) clearance. I'm being asked a similar question and would like to hear how you handled your situation. Thanks!