Medical Device Listing for 801(e) Export of Uncleared 510(k)able Device

K

Kiera

Guest
#1
Hello,

I am looking for information on how to acquire a device listing from FDA (if necessary) to support the export of a CE-marked Class IIa device which is as of yet uncleared by FDA.

FDA guidance on the topic indicates the need for a device listing (without which I am concerned the devices will not clear customs), but EU does not require a Certificate of Exportability, so I am not sure how to go about acquiring a listing number.

I welcome any suggestions/guidance.

Thanks,
K
 

MMBer

Starting to get Involved
#3
You have to register your facility with the FDA before you can list your products. The facility registration comes with an annual user fee of several thousand dollars. US manufacturers of export only devices are required to register. After your device is listed, you can apply for a certificate of exportability.
 

shimonv

Quite Involved in Discussions
#4
FDA guidance on the topic indicates the need for a device listing...
Hi Kiera,
Which guidance are you referring to? it sounds odd to me that you need to do listing with FDA for a device which is not distributed in the US (export only)?
Come to think about it, why should they care? and what is the point in listing a device which is not cleared/classified/codified accoring to FDA rules.

Shimon
 

MMBer

Starting to get Involved
#5
Google "Who must register and list FDA". The FDA website provides a list of which types of facilities must register with the FDA. US manufacturers of export only devices must register but I don't know how they would know about it if you don't. Technically, it also opens the possibility of an FDA inspection but you will be very far down on their priority list.
 

shimonv

Quite Involved in Discussions
#6
Thanks. Makes very little sense but you are correct.

I checked the CFRs and 21 CFR 807.20(a) says "An owner or operator of an establishment located in any State as defined in section 201(a)(1) of the Federal Food, Drug, and Cosmetic Act shall register its name, places of business, and all establishments and list the devices whether or not the output of the establishments or any particular device so listed enters interstate commerce"

Cheers,
Shimon
 
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