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Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013

AnaMariaVR2

Trusted Information Resource
#1
Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013
http :// www .fda. gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

1. ALL finished medical device contract manufacturers and contract sterilizers must register with the FDA (both domestic and foreign entities). Contract manufacturers and contract sterilizers who did not commercially distribute finished medical devices were previously exempt from the requirement to register. As of October 1, 2012, the final rule eliminates this exemption and applies the registration requirements to these companies as well. The FDA estimates that nearly 750 additional contract manufacturers need to register and list the medical devices that are handled by them.​
2. Finished device contract manufacturers and sterilizers now require their own US Agent.​
If the contract manufacturer or contract sterilizer is not established in the US (no physical address on US soil), the entity will also require a US Agent. As a manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user you must register, list and pay the annual fee. If your finished device is made by a non-US based contract manufacturer, it is very important that you make sure they have appointed a US Agent and registered with the FDA prior to October 1, 2012 to avoid potential supply interruptions.​
3. Foreign establishments must identify all US importers (distributors) of their device(s).​
Foreign establishments whose devices are imported into the United States must identify all importers known to them. This includes the name of each person who imports (or offers to import) the foreign establishment’s device into the United States.​
4. Your 510(k) or PMA number will be required when registering with FDA.​
If your device was cleared with a 510(k) submission, or through an approved Humanitarian Device Exemption (HDE) or Pre Market Approval (PMA), this number must be associated with the medical device listing. This will allow devices to be tracked on the basis of regulatory clearance number(s) which will improve the FDA’s post-market surveillance efforts.​
5. Single point of contact and brand names to be required in FURLS.​
The FDA collects device registration and listing information using an online system known as FURLS. The final rule requires that each owner or operator identify one contact person within their organization who will be responsible for creating a master account in FURLS for the owner or operator. Moreover, the FDA will require the proprietary and brand names under which each device is marketed to be listed in FURLS.​
 
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Elsmar Forum Sponsor
J

jayquality

#3
Re: Medical Device Establishment Registration and Listing - Notice of Changes for FY

3. Foreign establishments must identify all US importers (distributors) of their device(s).
Foreign establishments whose devices are imported into the United States must identify all importers known to them. This includes the name of each person who imports (or offers to import) the foreign establishment’s device into the United States.
What about sales by a foreign manufacturer directly to end users?
(They are not importers/distributors.)
For example, is it allowed to sell and ship directly to end users from Europe?
I assume yes, but can't find a definite answer on the FDA site.
(Assuming manufacturer is registered and device is listed).
 
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Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Medical Device Establishment Registration and Listing - Notice of Changes for FY

My understanding is that the US importer is the person first getting hold of the device in the US. In case of direct shipment from Europe to a US customer, that customer would assume the importer title.

Cheers,
Ronen.
 
M

MIREGMGR

#5
Re: Medical Device Establishment Registration and Listing - Notice of Changes for FY

Neither the law nor the written rules address the issue of device sales direct to end users, either professional or consumer. This kind of activity was rare in 1976, and of course is common now because of the internet.

My understanding is that FDA has never considered end-user recipients of devices shipped directly to them from outside the US to be subject to the "Initial Distributor" rule requiring Establishment registration. FDA is very interested in regulating such manufacturers, but...because of US regulatory politics, and also FDA's own internal workload...not at all interested in trying to get such end users to register as Establishments, as is required of Initial Distributors who are marketers.

I'm not normally a betting person, but I'd be willing to bet that under the revised rules being discussed in this thread, FDA won't change this approach.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Medical Device Establishment Registration and Listing - Notice of Changes for FY

Neither the law nor the written rules address the issue of device sales direct to end users, either professional or consumer. This kind of activity was rare in 1976, and of course is common now because of the internet.

My understanding is that FDA has never considered end-user recipients of devices shipped directly to them from outside the US to be subject to the "Initial Distributor" rule requiring Establishment registration. FDA is very interested in regulating such manufacturers, but...because of US regulatory politics, and also FDA's own internal workload...not at all interested in trying to get such end users to register as Establishments, as is required of Initial Distributors who are marketers.

I'm not normally a betting person, but I'd be willing to bet that under the revised rules being discussed in this thread, FDA won't change this approach.
:yes:

Sorry, I was thinking about (and referring to) direct shipment to retailers , while the question related to end-users... lack of attention on my part.

I agree 100% with MIREGMGR.

Ronen.
 
D

dcraig

#7
Re: Medical Device Establishment Registration and Listing - Notice of Changes for FY

I have a question regarding the last requirement regarding brand names and FURLS. I have e-mailed back and forth with the fda but cannot seem to get a straight answer. We private label many of our products for other customers. I am in a fight with management over whether or not a generic product labeled with another company name warrents inclusion in our listing. They do not believe that having a different companies name on the label qualifies as a brand. They believe it is only if they reference it as a specific product name.

Lets say for the sake of arguement we sell urology catheter. We list it as Urology catheter, Company X under our name and list the product but we also make it for another customer under their name but with us as manufacturer. They do not feel this needs to be listed as Urology Catheter, Company Y. Only if the label calls it something specific like Easy Glide Urology Catheter do we need to list it under the new regulations. The contract manufacturer part I get no problem but the private label aspect is throwing us off. Thank you for any input and if possible I need a guidence document or some source to quote. Thanks.
 
M

MIREGMGR

#8
Re: Medical Device Establishment Registration and Listing - Notice of Changes for FY

For many years, FDA has not required that the physical manufacturer of a "private labeled" device be identified on the product labeling, even though in this setting the physical manufacturer is regulatorily responsible for the device. This has caused problems many times when FDA has received a complaint or adverse event report and the end user has only known the information on the device label.

My understanding is that one of the purposes of the revised rule is to give FDA a database that identifies all such private labeled product versions, so that if FDA receives a complaint or adverse event report and the end user only knows the information on the device label, FDA can quickly cross-reference that information to identify the physical manufacturer.

Thus: yes, you must List each private label product version.

I would think that what you've heard from FDA would be consistent with this.
 
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