FDA - New Establishment Registration and Device Listing Requirements

bblbbblb

Inactive Registered Visitor
#1
We are a Canada based medical device manufacturer. Our FDA cleared IVD devices are manufactured by a contract manufacturer based here in Canada. The device is manufactured and shipped to use here in Canada. We sell and ship the device to distributors/customers in the USA. I was really hoping you someone could assist me with a couple of questions based on the New Device Registration and Listing Requirements

1. Our Contract Manufacturer in Canada is asking us for a list of our initial importers in the USA to complete their contract manufacturer listing with the FDA. As our Contract Manufacturer only ships the devices to us in Canada and does not ship to anyone directly in the USA, are they still required to provide this initial importer information in their FDA re-registration?
2. Many of our initial importers are our end user customers, for example hospitals and clinics. Do we need to include these in our list of initial importers with our FDA listing? Additionally, does this also mean that these end users/customers need to be registered/listed with the FDA?

I would really appreciate any help and assistance with these questions.
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MIREGMGR

Inactive Registered Visitor
#2
Re: New Establishment Registration and Device Listing Requirements

1. Our Contract Manufacturer in Canada is asking us for a list of our initial importers in the USA to complete their contract manufacturer listing with the FDA. As our Contract Manufacturer only ships the devices to us in Canada and does not ship to anyone directly in the USA, are they still required to provide this initial importer information in their FDA re-registration?
Under the old rules, no; but under the new rules, yes. The reporting requirement for all outside-USA contract manufacturers...even second-level, i.e. a contract sterilizer that works for a contract manufacturer...pertains to the US Initial Importer. For a Specification Provider in USA, generally they also act as the Initial Importer and the requirement is not a problem. For an outside-US specification provider, however, this is more difficult. The Initial Importer must have a US address, so an outside-US company cannot be a virtual Initial Importer. Nonetheless, that is the requirement.

2. Many of our initial importers are our end user customers, for example hospitals and clinics. Do we need to include these in our list of initial importers with our FDA listing? Additionally, does this also mean that these end users/customers need to be registered/listed with the FDA?
Yes and yes. This of course could be difficult, particularly in regard to updating your Listings every time a new customer is to be shipped to, and getting them to Register and pay the Registration fee.

Note that Initial Importers do not List, though.

The alternative would be to establish a company within USA to (formally) receive orders from end users, place orders with the home company, and serve as the Initial Importer. This requires that they take title to the goods entering US and then re-sell those goods to the end users, even if they don't physically handle those goods because they are direct shipped.

Note BTW that this latter course involves further complications pertaining to the upcoming Device Tax.
 

Ronen E

Just a person
Super Moderator
#3
Re: New Establishment Registration and Device Listing Requirements

A real roller-coaster!...

Interesting times indeed.
 

ascherp

Inactive Registered Visitor
#4
Many of our initial importers are our end user customers, for example hospitals and clinics. Do we need to include these in our list of initial importers with our FDA listing? Additionally, does this also mean that these end users/customers need to be registered/listed with the FDA?

We faced the exact same situation. To summarize the FDA's response: Hospitals and clinics do not need to register and list with the FDA, since they do not participate in the manufacture of medical devices. However, they do need to be included on your list of initial importers. So when you update your listings in FURLS, you proceed as follows:
1. Select the listing you want to update.
2. Click on "Add Importer".
3. When asked "Is this importer registered with FDA?", select "NO".
4. Provide the contact information of the hospital or clinic in the appropriate fields (name, address, telephone number etc.).
5. Click on "Add Importer".

If you need to add additional customers later on, just follow the same procedure each time.

Note regarding registration requirements for hospitals: The above statement is true for the great majority of hospitals and clinics. However, occasionally there are hospitals that do conduct manufacturing or remanufacturing activites, such as reprocessing single use devices, for which 510k clearance is required. In this case the hospital will be registered. So, just to make sure, you might want to ask your customers whether they are registered or check the CDRH Reg & Listing database. If the answer is no, the above procedure applies.
 
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MIREGMGR

Inactive Registered Visitor
#5
To summarize the FDA's response: Hospitals and clinics do not need to register and list with the FDA, since they do not participate in the manufacture of medical devices. However, they do need to be included on your list of initial importers.
Interesting. I'd previously heard the opposite regarding Registration.

I just called DSMICA to check. They stated that while it's true that hospitals and other end use facilities do not Register as user facilities, they do have to Register prior to the separate role of taking initial title to a medical device that is shipped to them from an outside-US company, i.e. the Initial Importer role.

I asked the DSMICA person to check that understanding, and she came back having received verification from someone else. So, at least two people at FDA have that understanding.

Initial Importers don't List, of course.

Given the information provided to Ascherp, it's possible that there may be some inconsistency regarding this issue at FDA.

My understanding of the reason for provision of the initial-importer-isn't-Registered functionality in the DRLM site code is to make it possible for a Manufacturer to properly report their Initial Importers even if those Initial Importers have not yet Registered. Then FDA can "remind" them of their retroactive obligation.
 

ascherp

Inactive Registered Visitor
#6
Hi MIREGMGR,

That is very interesting. There are definitely inconsistencies at the FDA. To my understanding, what you were told --by two people at the FDA!-- actually contradicts the wording of 21 CFR Part 807.3(g), which defines an Initial Importer as follows:

"Initial importer means any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package."

A hospital and clinic may receive the device from a foreign manufacturer, but is not furthering its marketing "to the ultimate consumer or user," since it already is "the ultimate consumer or user."

I will also check with our contact people at FDA and report back.
 

Doug Tropf

Quite Involved in Discussions
#7
Given the information provided to Ascherp, it's possible that there may be some inconsistency regarding this issue at FDA.
Seems to be a pattern of FDA inconsistency on the new listing requirements. I was informed by the FDA that the listing of our customer's devices (which we sterilize) had to be completed by November 1, 2012. One of our customers was advised by the FDA that the listing requirements must be completed by December 31, 2012. Who you gonna believe?
 
M

malu14

Guest
#8
Is anyone aware of a company SOP for FDA device listings and registrations? If so, can you share the document?
 

gxzn008

Inactive Registered Visitor
#9
Initial Importer - Takes first title to devices imported into the U.S. An Initial Importer must have a U.S. address.

According to this definition, if the outsider ship the product to hospital, so under this case, the hospital will be initial importer, and for initial importer, the hospital need finish establishment registration, but need not list the product.

So is my understanding right?
 

MIREGMGR

Inactive Registered Visitor
#10
Initial Importer - Takes first title to devices imported into the U.S. An Initial Importer must have a U.S. address.

According to this definition, if the outsider ship the product to hospital, so under this case, the hospital will be initial importer, and for initial importer, the hospital need finish establishment registration, but need not list the product.

So is my understanding right?
Yes.

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