Distributor v.s. Premarket Notification Question

R

regfocus

#1
Under 21 CFR 807.85 Exemption from premarket notification. It says:

(b) A distributor who places a device into commercial distribution for the first time under his own name and a repackager who places his own name on a device and does not change any other labeling or otherwise affect the device shall be exempted from the premarket notification requirements of this subpart if:
(1) The device was in commercial distribution before May 28, 1976; or
(2) A premarket notification submission was filed by another person.

My question is: why it says "under his own name"? If it is under distributor's name, then the distributor should be the manufacturer according to the manufacturer's definition by FDA. Then this distributor shall have its own premarket notification, however, the section (b)(2) says if "A premarket notification submission was filed by another person." then premarket notification is exempted.

Looks like conflict. Can someone give some explanation?
 
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M

MIREGMGR

#2
Re: Question: Distributor v.s. Premarket Notification

If it is under distributor's name, then the distributor should be the manufacturer according to the manufacturer's definition by FDA.
This is not correct. The FDA permits Manufacturers to sell devices to Distributors, labeled either under the Manufacturer's name or the Distributor's name; the latter approach is commonly called "private labeling". This is a very common way for medical devices to be provided to the marketplace.

The Manufacturer has full regulatory responsibility for devices sold in this manner. This therefore is distinct from contract manufacturing, in which the maker would have no regulatory responsibility and the buyer/contracting party would be the Manufacturer and would have full regulatory responsibility.

Devices sold by private-label distributors are permitted to not carry the name of the manufacturer; there is however an implied requirement that the private label distributor must notify the Manufacturer on a timely basis upon learning of a device incident, since the Manufacturer has responsibility for reporting such incidents to the FDA. There is no regulatory requirement, but it is common for Manufacturers to establish this notification requirement via contract with each of their private label distributors, so as to assure clarity in their mutual understandings of the business relationship and so as to be able to evidentiate to an FDA inspector that they have a system in place to meet their reporting obligations.

As noted by 21 CFR 807.85, private-label distribution does not create a requirement for a separate 510(k) from the one that the Manufacturer obtained in order to bring the device to the market. Neither, of course, would distribution under the Manufacturer's name.

All of the above becomes more complicated if the distributor sells devices outside of the US, and particularly if they sell within the EC, since the MDD differently defines the distribution role.
 
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R

regfocus

#3
Re: Question: Distributor v.s. Premarket Notification

MIREGMGR,

Thanks for your detailed explanation and make it more clear. Please let me ask further questions:

1) Your comments did not clarify if there is a conflict between "definition of the manufacturer" and "either under the Manufacturer's name or the Distributor's name". If it is UNDER the distributor's name, then the distributor should be the manufacturer according to the definition.

I agree the distributor can put some words on the labeling, such as "Distributed by XXXXX" or "Manufactured for XXXXX". Personally, I do not think these word means the device is distributed in U.S. UNDER the distributor's name. It is still UNDER the original manufacturer's name, so the distributor do not need to apply 510k.

Is my understanding correct?

2) For contract manufacturing, the original maker makes the device and sell to the buyer who will put his own information on the product, such as logo, name and address on the labelling. The device is to be sold by this buyer. In this case, the buyer definitely is the manufacturer according to the FDA and will have full regulatory responsiblity.






This is not correct. The FDA permits Manufacturers to sell devices to Distributors, labeled either under the Manufacturer's name or the Distributor's name; the latter approach is commonly called "private labeling". This is a very common way for medical devices to be provided to the marketplace.

The Manufacturer has full regulatory responsibility for devices sold in this manner. This therefore is distinct from contract manufacturing, in which the maker would have no regulatory responsibility and the buyer/contracting party would be the Manufacturer and would have full regulatory responsibility.
 
M

MIREGMGR

#4
Re: Question: Distributor v.s. Premarket Notification

If it is UNDER the distributor's name, then the distributor should be the manufacturer according to the definition.

I agree the distributor can put some words on the labeling, such as "Distributed by XXXXX" or "Manufactured for XXXXX". Personally, I do not think these word means the device is distributed in U.S. UNDER the distributor's name. It is still UNDER the original manufacturer's name, so the distributor do not need to apply 510k.

Is my understanding correct?
Whatever interpretation one makes of "under", this is current device regulatory practice:

A distributor arranges to purchase devices in quantity from a Manufacturer, arranges with the Manufacturer to have the devices labeled with the distributor's identification (and optionally not the Manufacturer's identification; this is the popular "private label" case), and sells that device into the US market.

Assuming that the Manufacturer properly holds a 510(k) for the device, a distributor will not obtain a separate 510(k) for that device, no matter whether the manufacturer's name is on the product label or not.

2) For contract manufacturing, the original maker makes the device and sell to the buyer who will put his own information on the product, such as logo, name and address on the labelling. The device is to be sold by this buyer. In this case, the buyer definitely is the manufacturer according to the FDA and will have full regulatory responsiblity.
Yes, agreed.

Commonly, the buyer specifies to the contract manufacturer the information that is to go onto the label, and the device is received by the buyer in completed labeled form, ready to market.
 
R

regfocus

#5
Re: Question: Distributor v.s. Premarket Notification

Whatever interpretation one makes of "under", this is current device regulatory practice:

A distributor arranges to purchase devices in quantity from a Manufacturer, arranges with the Manufacturer to have the devices labeled with the distributor's identification (and optionally not the Manufacturer's identification; this is the popular "private label" case), and sells that device into the US market.

Assuming that the Manufacturer properly holds a 510(k) for the device, a distributor will not obtain a separate 510(k) for that device, no matter whether the manufacturer's name is on the product label or not.
I see.

Question: if there is no clear identification to demonstrate who holds the 510(k), how FDA know this device is cleared by FDA or not?

For example, if FDA find a device sold in USA which is labeled with company A's name, but there is no records about A in FDA's 510k database. So the FDA will ONLY suspect the device is not cleared. In this case, FDA will spend much more time to figure out it is cleared or not until asking the company A.

Right?
 
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M

MIREGMGR

#6
Re: Question: Distributor v.s. Premarket Notification

For example, if FDA find a device sold in USA which is labeled with company A's name, but there is no records about A in FDA's 510k database. So the FDA will ONLY suspect the device is not cleared. In this case, FDA will spend much more time to figure out it is cleared or not until asking the company A.
This is hypothetical, since the FDA in practice does not review the status of marketed products unless either an incident occurs or complaint is filed, or the product pertains to a subject or issue of special importance to the FDA, i.e. the current focus on unapproved H1N1-influenza treatments and preventatives.

Yes, hypothetically if the FDA wanted to determine whether a private-label-distributed device was properly 510(k) cleared, they might have to contact the distributor, learn the identity of the Manufacturer, then review the appropriate database in regard to that company's Listed products. Yes, this would be cumbersome.

In practice, this rarely occurs, because the FDA does not monitor 510(k) status of most marketed products. The US medical device marketplace is substantially self-policed, with a very high rate of regulatory compliance.
 
R

regfocus

#7
Re: Question: Distributor v.s. Premarket Notification

:agree:Good!!!

Thank you so much for explanantion !!!
 
D

drewsky1

#8
Re: Question: Distributor v.s. Premarket Notification

I am still confused. What if we, as the potential distributor, develope a contract with the manufacturer and 510k holder to label and distribute the product with our branding, who holds the regulatory responsibility? We feel the IFU created by the 510k holder requires additional contraindications. Is this something we can recommend and they decide? I feel we have a responsibility to include these contraindications for the safety of the consumer. I was surprised that the FDA did not question or request the specific contraindication we feel should be on the IFU. Whether it is the manufacturer or the distributor, can adding a contraindication be a letter to file or does it require a new filing?
 
M

MIREGMGR

#9
Re: Question: Distributor v.s. Premarket Notification

(Hey, all you lurkers out there...this isn't the MIREGMGR-answers-questions forum. Feel free to jump in whenever you're ready.)

I am still confused. What if we, as the potential distributor, develope a contract with the manufacturer and 510k holder to label and distribute the product with our branding, who holds the regulatory responsibility?
The Manufacturer.

We feel the IFU created by the 510k holder requires additional contraindications. Is this something we can recommend and they decide? I feel we have a responsibility to include these contraindications for the safety of the consumer. I was surprised that the FDA did not question or request the specific contraindication we feel should be on the IFU.
You certainly can consider whether you think Product X's regulatory stance is correct in deciding whether to distribute it, and you certainly can suggest to the Manufacturer that they modify Product X's stance as a condition of your becoming a distributor. Those are business dealings, outside the FDA's purview.

Whether it is the manufacturer or the distributor, can adding a contraindication be a letter to file or does it require a new filing?
That's a complex question, dependent on the nature of the product and the original 510(k) filing. In the general case, I'd think that usually a new contraindication would be based on an analytical determination that the device might not be safe or effective in the circumstance in question. In that case, I'd think the FDA would expect a filing to explain how the original filing was wrong and the new understanding is correct, and what your stance is regarding devices already used inconsistently with the new contraindication.

You could pose your specific question to DSMICA--they are unlikely to tackle it themselves, but they may forward you to the actual deciders, who can give you authoritatively knowledgeable advice that is focused on your particular instance.
 
D

drewsky1

#10
Re: Question: Distributor v.s. Premarket Notification

Thanks for these clarifications. Very helpful. As this is a confidential issue in our business, can one remain anonymous with DSMICA?
 
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