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Private Labeled Devices with FDA Approval

This article answers one of the most common questions asked by non-US device firms, and by companies that want to import private labeled devices.

This article was initially inspired by a question asked on the Medical Devices Group website hosted by Joe Hage. Companies often ask about how to private labeled devices in the USA, because they are unable to find anywhere in the FDA regulations where private labeling of the device is described. The reason for this is because the FDA regulations for devices allow for the labeling to identify the distributor only—without any mention of the OEM manufacturer on the label. In contrast, most other countries have “own-brand labeling” regulations or regulations for private labeling devices. It is also important to remember that the FDA only approves devices through the pre-market approval (PMA) pathway. All other devices fall into one of three categories: 1) 510(k) exempt, 2) 510(k) cleared, or 3) De Novo classification request approved. Devices that fall into the third category will subsequently fall into category 1 or 2 after the FDA approves the classification request.

Questions about the private labeled devices process for FDA

Our distribution company is interested in getting a private labeled devices agreement with an OEM to sell a Class II medical device in the USA. The OEM has 510(k) clearance, and the only product change will be the company’s name and address on the label. There will be no change to the indications for use. Please answer the following questions:

  1. Is it legal to eliminate all mention of the OEM from the device labeling?
  2. Who is responsible for complaint handling and medical device reporting? OEM or private-labeled distributor?
  3. What is the process to get this private label for the Class II device?
  4. How can our distribution company avoid paying the FDA user fee?

Answer to the first question about private labeled devices

The FDA is unique in that they allow either the distributor or the manufacturer to be identified on the label, but both are not required. Therefore, if Joe Hage were the distributor, and you were the manufacturer, there are two legal options for the private labeled device: 1) “Distributed by Joe Hage”, or 2) “Manufactured for Joe Hage.”

The manufacturer is not required to be identified on the label. However, the OEM must be registered and listed with the FDA. If the OEM is outside the USA, then the distributor must register and list with the FDA as the initial importer and reference the K number when they complete the FDA listing. There is no approval required by the FDA. You will need a quality agreement defining the roles and responsibilities of each party, but that is all.

Answer to the second question about private labeled devices

The quality agreement must specify which company is responsible for complaint handling (21 CFR 820.198) and medical device reporting (21 CFR 803). In this situation, the OEM is the specification developer, as defined by the FDA. Therefore, the OEM will be responsible for reporting and execution of recalls. Therefore, even if the distributor with a private label agreement is identified as the “complaint file establishment,” the OEM will still need to obtain copies of the complaint information from the distributor, and determine if medical device reporting and/or corrections and removals are required (i.e., recalls).

Answer to the third question about private labeled devices

There is no formal process for “getting a private label.” The entire private label process is negotiated between the distributor and the OEM with no involvement of the FDA. However, in the listing of devices within the FDA FURLS database, all brand names of the device must be identified. Therefore, the OEM will need to add the new brand name used by the distributor to their listing for the 510(k) cleared product. However, the FDA does have the option to keep this information confidential by merely checking a box in the device listing form.

Answer to the fourth question about private labeled devices

If the distribution company is the initial importer of a device into the USA, then the distributor must be registered with the US FDA as the initial importer, and the distributor will need to pay the FDA user fee for the establishment registration. That user fee is $5,236 for FY 2020, and there is no small business discount for this fee. The only way to avoid paying the user fee is to have another company import the device, who is already registered with the FDA, and to distribute the product for that company. I imagine some logistics brokers might be acting as an initial importer for multiple distributors to help them avoid paying the annual FDA user fee for establishments. That company might also be providing US Agent services for multiple OEMs. However, I have not found a company doing this.

Is private labeling of device legal in the USA?

The FDA is unique in that they allow either the distributor or the manufacturer to be identified on the label, but both are not required. Therefore, if Joe Hage were the distributor, and you were the manufacturer, there are two legal options for the private label: 1) “Distributed by Joe Hage”, or 2) “Manufactured for Joe Hage.”

Who must register, list, and pay user fees for medical devices?

This question is frequently asked, and the table with the information was not visible on my mobile browser. Therefore, I copied the table from the FDA website and posted the information in the image below. The information is copied directly from the FDA website:

Registration and Listing Requirements for Domestic Establishments

Who must register list and pay fig 1 1024x697 Private Labeled Devices with FDA ApprovalWho must register list and pay fig 2 1024x710 Private Labeled Devices with FDA Approval

Registration and Listing Requirements for Foreign Establishments

Who must register list and pay fig 3 1024x947 Private Labeled Devices with FDA Approval

For products that are manufactured outside the USA, and imported into the USA, the initial importer is often the company identified on the label. There are two typical private labeling situations, but other possibilities exist:

  1. If the initial importer owns the 510(k), then the manufacturer outside the USA is identified as the “contract manufacturer,” and the initial importer is identified as the “specifications developer.” Both companies must register their establishments with the FDA, and there needs to be a quality agreement between the two companies defining roles and responsibilities. The contract manufacturer outside the USA is not automatically exempt from reporting requirements and complaint handling. The contract manufacturer outside the USA may decide to label the product as a) “Manufactured by”, b) “Manufactured for”, or c) “Distributed by.” Options “a”, “b” and “c” would list the importer’s name because they own the 510(k), and they are the distributor. This situation often occurs when companies outside the USA want to sell a product in the USA, but they do not want to take on the responsibility of obtaining 510(k) clearance. These firms often believe this will exempt them from FDA inspections, but the FDA is increasingly conducting FDA inspections of contract manufacturers due to this private label situation.
  2. If the manufacturer owns the 510(k), then the manufacturer outside the USA is identified as the “specifications developer” and the “manufacturer,” while the initial importer will be identified as the “initial importer.” The importer may also be specified as the complaint file establishment and/or repackager/relabeler in the FDA registration database. The manufacturer outside the USA will not be able to import the device into the USA without identifying an initial importer in the USA in the FDA FURLS database. The manufacturer outside the USA may decide to label the product as a) “Manufactured by”, b) “Manufactured for”, or c) “Distributed by.” Options “b” and “c” would list the importer’s name, while option “a” would list the manufacturer’s name. This situation often occurs when US companies want to be the distributor for a product made outside the USA, and the company wants a private labeled product. This also happens when the OEM wants the option to have multiple US distributors.

In both of the above private-label situations, the non-US firm must have a US Agent identified because the company is located outside the USA. The US Agent may be the initial importer, but this is not required. It could also be a consulting service that acts as your US Agent. The US Agent will be responsible for receiving communications from the FDA and confirming their role as US agents each year when the registration is renewed. Medical Device Academy offers this service to non-US clients we help obtain 510(k) clearance.

Follow-up questions

A Korean company, with a US distribution subsidiary, would like to private label a medical device with an existing 510(k) owned by another company in their name. Does the Korean company need a contract in place before private labeling? Does the US subsidiary and/or the Korean parent company need to be registered in the USA prior distribution of the private-labeled version of the device in the USA?

Rob’s response: Initially, it was unclear from the wording of the question as to whom is the 510(k) owner, which company will be on the label, who is doing the labeling, and who is doing the importing to the USA. The person asking Joe Hage this question tried clarifying their question via email, but we quickly switched to scheduling a phone call using my calendly link. I have reworded the question above, but here are some of the important details I learned during our phone call:

  1. The person asking was already acting as the relabeler, repackager, and they were distributing the product in the USA. This person’s company is also registered with the FDA.
  2. The device is 510(k) cleared by another US company, and there is no need to worry about the complications of an initial importer being identified for a product manufactured in the USA.

In this situation, the relabeler/repackager can relabel the product for the Korean company’s US subsidiary as long as there is a quality agreement in place for all three parties (i.e., relabeler, distributor, and manufacturer). There is no need for the Korean parent company to register with the FDA. There is no need for a new 510(k) submission, and the US subsidiary does not need to register with the FDA—as long as the quality agreement specifies that the US subsidiary will maintain records of distribution, facilitate recalls if required, and notify the manufacturer of any potential complaints and/or adverse events immediately. The manufacturer with 510(k) clearance will be responsible for complaint handling, medical device reporting, and execution of recalls according to the agreement. The relabeler will be responsible for maintaining records of each lot of product that is relabeled for the US subsidiary, and the relabeler must maintain distribution records that link the original manufacturer’s lot to the lot marked on the relabeled product.

If you have questions about the private labeling of your device, please contact us.

Posted in: FDA

Leave a Comment (16) ↓

16 Comments

  1. davidraino February 11, 2020

    The proper Medical Device labeling service is required to control unnecessary human exposure to potentially hazardous ionizing and nonionizing radiation, and to ensure the safe, efficacious use of such radiation.

    reply
  2. Mokgat May 7, 2020

    Hello !
    This article is very interesting and full of precious information !
    I would like to know if there is any quality agreement template for this typical situation (private labeling with a relabeler).

    Thanking you in advance,

    reply
  3. Aramac July 22, 2020

    Hi Bob,
    Nice article.

    Just curious to know whether the OEM must have the 510(k) approved for the product before private labeling. or there is an option where the private labeler will take the OEM product brand it in his name , obtain 510(K), register with FDA and place the product in the US Market.

    Appreciate your help in advance.

    Thank

    reply
    • Rob Packard July 23, 2020

      Thank you for the positive feedback on the article. If the product is a Class 1 exempt or Class 2 exempt device, then a 510(k) is not required by either company. If the product requires a 510(k), then the 510(k) is required before either company can register with the FDA. In the situation you described, the OEM is actually considered a contract manufacturer with the FDA. You would be the specifications developer and initial importer, while the OEM registers as a contract manufacturer. However, neither company can register the product without a K number.

      reply
  4. Ting August 7, 2020

    Hi Bob,

    This article is very informative and very easy to understand. It answers lots of questions one might face during dealing with listing for the 1st time.

    To the third question about private labeled devices, does the OEM need to do add to file due to new brand name used by distributor before adding it to listing of the 510K cleared product?

    Thank you in advance.

    reply
    • Rob Packard August 23, 2020

      Thank you for your question.

      The OEM needs to update the listing information to indicate the new brad name, and this would also require updating the Device Master Record (DMR) for any labeling if it is done by the OEM for the distributor.

      Rob

      reply
  5. Aneesha September 15, 2020

    Hi Rob,

    This article is very informative and helpful,
    If we are the initial importers of the products(Class I not exempt)based in US. The products are manufactured in Thailand which already hold a 510(k). We want to Relabel/ Re-brand them under our own brand name.
    My question is can we hold a separate 510(k) for the products?

    Appreciate you help in advance

    Thank you

    reply
    • Rob Packard July 17, 2021

      Yes, you can obtain your own 510(k) for the device. However, you are not “relabeling/re-branding” in this scenario. You are becoming the specification developer, and the supplier is the company you are outsourcing design to and manufacturing. You will also have to comply with the current standards and testing requirements. You may be able to provide a biocompatibility certification statement instead of doing your own biocompatibility testing, but you would need documentation from the supplier to support that as well.

      reply
  6. Matthew J Miller October 16, 2020

    Never have I seen such a clear explanation for an FDA regulated process.
    Thank you!

    reply
  7. Michal February 18, 2021

    Hi Rob,
    Thank you for the very informative article.
    I do have an additional scenario which I would like to have your insight on:
    A non-US company would like to distribute under its brand name a device to the US market. The device is manufactured by another non-US manufacturer (OEM) which own a 510K for the device.
    The distributer has a US agent which also acts as an initial importer for other devices.
    How to label the device and who is responsible and liable for the products.

    Thanks in advance

    reply
    • Rob Packard July 17, 2021

      There should be quality agreements that are established between the OEM, the distributor, and the US agent. The quality agreement should specify roles and responsibilities for each party. Typically a US agent is not an initial importer too, but if the US agent is also providing this service they will need to maintain distribution records, and they will need to be responsible for storage, handling, and shipping of the devices. Usually, the initial importer will require that they are indemnified by under the liability insurance, because they would not have control over design, manufacturing, or labeling of the product.

      The OEM must be identified as the specification developer in the registration, because they own the 510(k). They also control the manufacturing of the device. The OEM is probably also applying the labeling for the distributor. Therefore, this organization will typically hold the liability insurance for the product, and they would be the primary establishment for FDA inspections. Depending upon the agreement, they may or may not be responsible for compliant files related to the product with the distributor’s name. But the agreement would state the distributor would communicate complaints they receive to the OEM so the OEM can perform investigations of root cause–and potentially recall product. Since the distributor’s name is on the product, the distributor will need to assign the “DI” portion of the UDI number.

      Finally, the distributor is responsible for verifying that the US Agent is maintaining distribution records and maintaining the data in the GUDID. They will probably be identified as the complaint file establishment.

      reply
  8. Nick March 29, 2021

    What would be the labeling requirements where the design and specification developer is in the US but has a contract manufacturer doing all of the manufacturing with FG release? Does the CM have to be listed on the label or can only the design/specification developer be listed as the “Manufacturer”? Thank you

    reply
    • Rob Packard July 17, 2021

      The US company can be listed as the specification developer and complaint file establishment, and the CM can be listed as a “manufacturer.” However, the label in the US will then be marked with “Manufactured for” instead of “Manufactured by”.

      reply
  9. Flo August 26, 2021

    Hello Rob!

    Thank you very much for this great information!
    I have a question for you. I am a company based in Canada, and my supplier already has the 501(k) for this medical device.
    I want to Private Label this Medical Device and sell it on Amazon in the US.
    So Amazon will do all the storage, shipping and handling.
    Will it affect me as being the Initial Importer in any way? I will still have to go through the exact same process and laid out in your article?

    Thank you very much!

    reply
    • Rob Packard August 29, 2021

      Unfortunately, even though Amazon is the initial importer you will be considered the complaint handling establishment and repackager/relabeler. Even though your supplier has a 510(k) and they will be labeling the product for you, if your name is on the product you will be responsible for 3 things:
      1. registration as complaint file establishment
      2. registration as repackager/relabeler, because your name is on the label
      3. applying for a GUDID account with FDA and assigning the DI portion of the UDI barcode for your product (your supplier will assign the PI portion); this includes uploading the GUDID data elements into the FDA database

      Amazon will be the initial importer and they will maintain records of distribution.

      As the repackager/relabeler you also need a quality system and you are subject to FDA inspection. Even though your supplier will do most of the work, you still need to control them as a supplier and make sure all of the outsourced activities are being performed. This typically involves customer audits, but this might be a remote audit. You will need to execute a supplier quality agreement with the supplier that articulates roles and responsibilities for both sides.

      Rob

      reply

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