New Establishment Registration and Device Listing Rule - August 2012

M

MIREGMGR

#21
Clearly US FDA is headed for a system where most regulated activities have to be reported to a database by both the buyer and the seller, using terminology and formats that permit algorithmic matching. Thus they will be able to run reports that will identify mismatches, and their human resources can focus on those problem-points and can (relatively) ignore the properly matched reporters.

If your supplier doesn't correctly List your devices, you and they will end up on that mismatch list, and you and they will get heightened scrutiny so that FDA can determine which of you doesn't conform.

So, maybe ultimately it'll be their hand that's slapped, but it will have a regulatory-attention cost for you too.

Of course I don't know when this future will begin, and there are steps yet to be taken.
 
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sreenu927

Quite Involved in Discussions
#22
Hi,

I have a similar question.

1. Does the "accessories" contract manufacturer requires registration?
2. Does the "GPR/GPLE (General Purpose Reagent/General Purpose Laboratory Equipment) Contract manufacturer requires registration and listing?

Thanks,
SReenu
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#23
Hi,

I have a similar question.

1. Does the "accessories" contract manufacturer requires registration?
2. Does the "GPR/GPLE (General Purpose Reagent/General Purpose Laboratory Equipment) Contract manufacturer requires registration and listing?

Thanks,
SReenu
What class are the accessories??
 

sreenu927

Quite Involved in Discussions
#24
Hi Kevin,

We plan to submit our 510(k) for the SYSTEM. So this system includes instrument and accessories. Specifically, we don;t classify accessories.
In case, if we want to classify them they are Class I and no intention to submit registration of these accessories separately.

Thanks,
Sreenu
 
M

MIREGMGR

#25
1. Does the "accessories" contract manufacturer requires registration?
If what the supplier ships to you is a finished device in its own regard...or a finished accessory, distinct from the device or system with which it is intended to be used and not necessary for the basic functionality of that system but modifying or extended that functionality when present, so that it (the accessory) is regulated as if it is a device...then the supplier in fact is a Contract Manufacturer as you state. All Contract Manufacturers must Register and List.

If on the other hand the supplier ships you an "accessory" that more properly is described as an element of your system, without the inclusion of which your system is incomplete in regard to performing its basic medical device function, then I would think the supplier should be regarded as a 21CFR 807.65(a) component maker and not a Contract Manufacturer. Component makers do not Register or List.
 

sreenu927

Quite Involved in Discussions
#26
Hi MIREGMGR,

Thanks for your reply! I am hoping the same.
However, we are still evaluating the situation how to sell these so called "accessories".
The supplier ships the finished goods and hence considered as contract manufacturer, if we:
- sell these products individually - needs registration and listing!
and as a Component Supplier if we
- sell as part of the instrument - no registration and listing!

How about the case, if we supply these products as accessories to the instrument and also sell them individually (customer orderable consumables)?
In this case, does the supplier is treated as 'component supplier' or 'contract manufacturer'?

Thanks,
Sreenu
 
M

MIREGMGR

#27
How about the case, if we supply these products as accessories to the instrument and also sell them individually (customer orderable consumables)?
In this case, does the supplier is treated as 'component supplier' or 'contract manufacturer'?
Gray area.

Suppose you sell a system that includes a printer, which prints on a roll of special paper, which you get from a special-paper supplier. You sell the paper under your name. In my view, that supplier is a component maker, and the roll of paper is not a device so you don't need to treat it as such when you sell it to the end user as a consumable-replacement.

But:

Suppose you sell scalpels that use replaceable blades, which you get from a blade maker that makes many types of blades, but not blade holders. You sell the blades as consumable-replacements under your name. The FDA regards scalpels as medical devices, of course, but it also regards scalpel blades as devices. So, your blade supplier is a Contract Manufacturer...even though historically they have thought of themselves as just a blade maker, not a medical device company...and has to Register and List.

To the best of my knowledge, the boundary lines in this territory are not defined in writing. I think the decision-basis historically has been: if the object either has patient contact or substantially determines the overall device/system's safety or efficacy, the object may be a device. Otherwise it's not.

Of course, you have to start any such determination by searching the Product Code database to see if your object appears there in some manner.
 

sreenu927

Quite Involved in Discussions
#28
Hi MIREGMGR,

Many thanks for your analysis, as always:)
Well quoted examples.

For our case, these are GPLE labeled (considered as Class I medical devices) products to be supplied along with IVD labeled instruments.

I think the risk is low, considering the fact that these are not in contact with patient and labeled as GPLE!

Thanks alot!
Sreenu
 

Ajit Basrur

Staff member
Admin
#29
Hi MIREGMGR,

Many thanks for your analysis, as always:)
Well quoted examples.

For our case, these are GPLE labeled (considered as Class I medical devices) products to be supplied along with IVD labeled instruments.

I think the risk is low, considering the fact that these are not in contact with patient and labeled as GPLE!

Thanks alot!
Sreenu
What is GPLE ?
 
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