Question on Device Listing for a FDA registered facility

SGquality

Quite Involved in Discussions
#1
Friends,

I am in urgent need of an answer - this refers to one of our FDA registered establishment in Mexico, where we manufacture finished devices.

I wanted to know when should we list the new device that is intended to be commercially distributed in Jan 2014. I am of the view that the device listing should be done within 30 days of the first launch of the device in the market but my Logistics Manager noted that he may have isssues at the CBP (Customs and Border Protection) when we send the Engineering and other trial samples to the customer in US.

Is this true ? Any thoughts on the timeline for device listing would be of immense help

Thank you !
 
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sagai

Quite Involved in Discussions
#2
Let me ask a question.
So you are asking if for US market a medical device can be commercialised without having a market clearance?
Regards
 

SGquality

Quite Involved in Discussions
#3
Oh I forgot to give this info - we are a contract manufacturer. The customer will have their PMN and then we as a contract manufacturer will use the customer's PMN to do the device listing in the DRLM system.

I wanted to know when should we do this listing in the DRLM ? And whether sending Engineering or Trial samples would require this listing ?
 
M

MIREGMGR

#5
whether sending Engineering or Trial samples would require this listing ?
If those units will be used on patients, they will be devices and should be listed so as to avoid border crossing problems. The customs broker has to report the devices via FDA PREDICT, which requires that the Listing number be provided and that it match up with DRLM.

If they will not be used on patients, make clear in your terminology for the units you ship that they are not finished devices. Then no Listing is required for importation.

...we are a contract manufacturer. The customer will have their PMN and then we as a contract manufacturer will use the customer's PMN to do the device listing in the DRLM system.

I wanted to know when should we do this listing in the DRLM ?
You must be coordinated with the responsible Manufacturer/Specification Provider. You cannot List before them, but you also should not wait to List very long after they have done so.

Note that if they have not yet Listed so you have not Listed either, and you try to ship finished devices into USA, your broker probably will fail the PREDICT-test and your shipment might be blocked. So, in your instance, the legacy 30-days-after-marketing rule may not be practically useful.
 

SGquality

Quite Involved in Discussions
#6
If those units will be used on patients, they will be devices and should be listed so as to avoid border crossing problems. The customs broker has to report the devices via FDA PREDICT, which requires that the Listing number be provided and that it match up with DRLM.

If they will not be used on patients, make clear in your terminology for the units you ship that they are not finished devices. Then no Listing is required for importation.
Yes, I thought as much ... the samples will not be tested on humans but for study on dimensions and related tests. ... so my broker is not well informed. Is this on either FDA / CBP website ?

You must be coordinated with the responsible Manufacturer/Specification Provider. You cannot List before them, but you also should not wait to List very long after they have done so.

Note that if they have not yet Listed so you have not Listed either, and you try to ship finished devices into USA, your broker probably will fail the PREDICT-test and your shipment might be blocked. So, in your instance, the legacy 30-days-after-marketing rule may not be practically useful
Yes, we will register the device on DRLM once the commercial production starts.
 
M

MIREGMGR

#7
Is this on either FDA / CBP website ?
To the best of my knowledge, the operation of the FDA PREDICT system still is not openly documented. We know about it from talking directly with FDA border-district people and PREDICT development people in Maryland, and from FDA training materials for brokers that FDA showed us.

FDA PREDICT isn't operated by CBP, so I'm not aware that they intend to document it.
 
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