21 CFR 820 Applicability to a Marketing Company

DannyK

Trusted Information Resource
#1
A marketing company has arranged to manufacture a class II medical device in a foreign country that will be sold in the USA. The supplier of the medical device will label the medical device with the marketing company's name. The marketing company will provide customer support and handle recalls, and complaints.

The supplier is already registered with the FDA.

Does the marketing company need to get establishment registration with the FDA?

Does the marketing company need to comply with 21CFR820 and if yes, why?

Thanks for your help.

Danny
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
A quick "Bump". Any thoughts, folks? My Thanks in advance!
 

Ronen E

Problem Solver
Staff member
Moderator
#3
A marketing company has arranged to manufacture a class II medical device in a foreign country that will be sold in the USA. The supplier of the medical device will label the medical device with the marketing company's name. The marketing company will provide customer support and handle recalls, and complaints.

The supplier is already registered with the FDA.

Does the marketing company need to get establishment registration with the FDA?

Does the marketing company need to comply with 21CFR820 and if yes, why?

Thanks for your help.

Danny
Hi,

My answer to both your questions is YES! The reason is that the product is (apparently) going to be sold in the USA under the marketing company's name, and therefore it will be considered "the manufacturer" by the FDA.

The terminology you use is a bit off the FDA's one. The entity you refer to as "the marketing company" will be considerd "a manufacturer" and the one you termed "the supplier" is a "contract manufacturer" according to FDA terminology. That is, if I got you right... :D

Cheers,
Ronen.
 
M

MIREGMGR

#4
I disagree that the marketing company is automatically the Manufacturer because the device is labeled with their name. That would not be the case, for instance, in a private labeling scenario.

If the marketing company acts only as a distributor, and if the actual maker Lists the product, then definitely the maker is the Manufacturer, irrespective of whether the product is labeled with their name or private labeled with a distributor's name.

If on the other hand the marketing company Lists the product and holds the product 510(k) (if applicable), then they are the Manufacturer.

The Manufacturer, whichever company it is, must be fully compliant with FDA requirements, including 21CFR 820. If the maker is the Manufacturer, the distributor must Register and has certain other regulatory responsibilities, because they are the Initial Importer of a device that is made outside the USA. If the maker is not the Manufacturer, then they are a contract manufacturer and would not be required to register or conform to most regulations, except in regard to sterility. However, since they already are registered, there is precedent for the FDA expecting them to conform to most regulations even though the guidance says it is not required.

Whether the marketing company ends up as the Manufacturer or as a distributor and Initial Importer, they must Register. If however they were distributing a product made in USA, and they did not hold the 510(k) and List the product, they would not be required to Register.
 
Last edited by a moderator:

DannyK

Trusted Information Resource
#6
I would like to thank everyone for their help.

Am I right in saying that if the marketing company is considered a repacker or relabeler, the company has to conform to 21CFR820?

If the company is considered a foreign exporter, is it required to conform to 21CFR820?

The situation is that the " marketing company" or "Foreign exporter" has hired a company in the Far East to design and manufacture a class II medical device.

The medical device will be fully complete including all required labels and will be shipped to a warehouse in the USA. Orders will arrive to the "Foreign exporter" and they will provide the shipping information to the warehouse to ship the product out to the customer.

The "Foreign exporter" will be responsible for complaints and returns?

Am I correct in classiying the company as a foreign exporter for the FDA?

Can the subcontractor file the 510k on behalf of the "foreign exporter"?

Are there any private label options for the foreign exporter that they can piggyback on the Subcontractor ? Where can I find further information? I could not find it on the FDA website.

I appreciate your help.
 
#7

Ronen E

Problem Solver
Staff member
Moderator
#8
I would like to thank everyone for their help.

Am I right in saying that if the marketing company is considered a repacker or relabeler, the company has to conform to 21CFR820?

If the company is considered a foreign exporter, is it required to conform to 21CFR820?

The situation is that the " marketing company" or "Foreign exporter" has hired a company in the Far East to design and manufacture a class II medical device.

The medical device will be fully complete including all required labels and will be shipped to a warehouse in the USA. Orders will arrive to the "Foreign exporter" and they will provide the shipping information to the warehouse to ship the product out to the customer.

The "Foreign exporter" will be responsible for complaints and returns?

Am I correct in classiying the company as a foreign exporter for the FDA?

Can the subcontractor file the 510k on behalf of the "foreign exporter"?

Are there any private label options for the foreign exporter that they can piggyback on the Subcontractor ? Where can I find further information? I could not find it on the FDA website.

I appreciate your help.
Hi,

I feel I'm still missing some details regarding the overall setting, but I'll give it a try anyway:

Repackers and relabelers are subject to the applicable sections of part 820 (some guidance is available from the FDA).

Regarding your questions pertaining to "Foreign Exporter", it depends on whether that's all a company is, or does it have other roles in the supply chain that can render it "a Manufacturer", an "Initial Distributor" etc. I'm still not sure who's going to actually place the product on the US market, and who's going to be identified on the labelling as "owning" the product (i.e. taking regulatory responsibility) in the US.

Who owns / operates the USA warehouse? Who is the entity formally importing the product into the USA? Are the customers directly serviced by this USA warehouse located inside or outside the USA?

Complaints and returns can be handled by either the Initial Distribotor in the USA or by an the Foreign Exporter; either way, the regulatory responsibilty will stay with the entity placing the product on the market.

As far as I know there is no problem with the subcontractor submitting the 510(k), as long as it is guaranteed that the product eventually placed on the market is identical to the product cleared by the 510(k).

If the foreign exporter is also a distributor in the USA, the labelling can state that without necessarily implicating full regulatory resposibility (if that's what you meant by piggyback onto the subcontractor). This issue was discussed here in past threads (not too long ago) with some useful information from others.

Cheers,
Ronen.
 
M

MIREGMGR

#9
Am I right in saying that if the marketing company is considered a repacker or relabeler, the company has to conform to 21CFR820?
Yes, per http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm.

If the company is considered a foreign exporter, is it required to conform to 21CFR820?
The FDA doesn't define or use the term "foreign exporter" in regard to US companies that are importing products, so I respectfully suggest that using that term in trying to describe your scenario doesn't help to achieve clarity.

A marketing company that buys a product from a maker outside the US, for shipment by the outside-US maker to the marketing company, and intends to sell that product as a medical device within the US is in FDA terms an Initial Importer.

The "Foreign exporter" will be responsible for complaints and returns?
If the marketing company...the distributor and Initial Importer...holds the 510(k) and has Listed the device, then yes, the marketing company will be responsible for complaints, and potentially for Adverse Event reports.

("Returns" are a business issue, not affected by regulatory requirements, unless the reason for the return is a complaint pertaining to safety or effectiveness or the return is in response to a recall or other field action.)

If the maker holds the 510(k) and Lists the product, and the maker (as an outside-US device maker) has designated the marketing company as its US Agent in addition to their regulatory role as Initial Importer, then the marketing company will be co-responsible with the maker for complaints and Adverse Event reports.

If on the other hand the maker holds the 510(k) and Lists the product, and the maker (as an outside-US device maker) has a US Agent other than the marketing company and Initial Importer, then probably the US Agent on behalf of the maker is legally responsible for complaints and Adverse Event reports. (I say "probably" because this will be legally complex and could be affected by the terms of the contracts involved.)

Am I correct in classiying the company as a foreign exporter for the FDA?
I don't know what you mean by "foreign exporter". In the scenario you've described, the marketing company will be an Initial Importer.

Can the subcontractor file the 510k on behalf of the "foreign exporter"?
Is the "subcontractor" the outside-US maker? If so, certainly they can hold the 510(k), and also List the product. In that case, they are legally the Manufacturer.

Are there any private label options for the foreign exporter that they can piggyback on the Subcontractor ?
I don't understand what's being asked here.

If you want to better understand the FDA labeling rules, including private labeling, see for instance http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM095308.pdf.
 

DannyK

Trusted Information Resource
#10
MIREGMGR, Thanks for the detailed response.

I used the term "Foreign Exporter" since it describes the marketing company. The company is not based in the USA and will export devices from the Far East to the USA to be distributed in the USA and other parts of the world.

The definition from the FDA page that you referenced was as follows:

Foreign Exporter - Exports or offers for export to the United States (U.S.), a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
 
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