Regulatory Open Forum

Fellow colleagues,

Hope all is well.  In reading the regulations, it seems that proprietary names and brand names are used interchangeably.  While the FDA recommends that we list all proprietary names under which a device is marketed in the US, it also states that at least one proprietary name or brand name be listed.  

I interpret it to mean that say we sell condoms under the overall brand XYZ, but under that brand we have several condom sub-types, example, HHC, ZTE, etc.  Would the sub-types be considered the proprietary names and required to be listed, or would simply listing XYZ as the overall brand suffice when listing in the establishment listing database? 

The question is posed because management wishes to keep the sub-type names confidential.  I have advised that the option to make each confidential is available, but they would like to explore the possibility of listing only the overall brand, and not all the proprietary names for the various device types.

Hope this is clear.


Thanks much, and happy Friday!


Laura

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Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
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Hi Laura

My understanding of the confidential listing option is that it allows preservation of confidentiality agreements between contract manufacturers and private labelers.

I am not aware of sublistings options in the FURLS module.

As you probably know, listing a product as confidential only prevents the general public from seeing the listing; that information is still accessible by FDA personnel.

By not listing HHC, ZTE, etc, your company is exposing itself to the risk of there being an issue with the product, with the follow-on problem of the FDA investigator not being able to determine the manufacturer / relabeler / initial distributor from the databases accessible to him / her. The result of that would be an accusation of regulatory misconduct.

https://www.fda.gov/MedicalDevices/Safety/ReportingAllegationsofRegulatoryMisconduct/default.htm

If this were my situation I would be vehemently opposed to not listing those products. At the very least I would advise management that not listing constitutes regulatory misconduct according to FDA.

Good luck!

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Jean Bigoney PhD, RAC
Managing Member
Murphy NC
United States
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Original Message:
Sent: 16-Mar-2018 13:56
From: LAURA HOSHUE
Subject: Establishment listing - Proprietary names (or brand names)

Fellow colleagues,

Hope all is well.  In reading the regulations, it seems that proprietary names and brand names are used interchangeably.  While the FDA recommends that we list all proprietary names under which a device is marketed in the US, it also states that at least one proprietary name or brand name be listed.

I interpret it to mean that say we sell condoms under the overall brand XYZ, but under that brand we have several condom sub-types, example, HHC, ZTE, etc.  Would the sub-types be considered the proprietary names and required to be listed, or would simply listing XYZ as the overall brand suffice when listing in the establishment listing database?

The question is posed because management wishes to keep the sub-type names confidential.  I have advised that the option to make each confidential is available, but they would like to explore the possibility of listing only the overall brand, and not all the proprietary names for the various device types.

Hope this is clear.


Thanks much, and happy Friday!


Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

I have seen the term proprietary name, brand name, trade name, etc. all used interchangeably; as far as I know there is no prevention from using the product name under any of these.  In the pre-market notification scheme, they use the term Trade Name and Brand Name.

Concerning your question about listing, I would use caution as well not listing everything that you are manufacturing and distributing.  As indicated, there is an ability to make names confidential for contract manufacturers and third parties involved that should be considered.  If you do not list the names, during an FDA inspection there may be some difficult questions that you have to answer why a product is not listed.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs
------------------------------

Original Message:
Sent: 16-Mar-2018 13:56
From: LAURA HOSHUE
Subject: Establishment listing - Proprietary names (or brand names)

Fellow colleagues,

Hope all is well.  In reading the regulations, it seems that proprietary names and brand names are used interchangeably.  While the FDA recommends that we list all proprietary names under which a device is marketed in the US, it also states that at least one proprietary name or brand name be listed.

I interpret it to mean that say we sell condoms under the overall brand XYZ, but under that brand we have several condom sub-types, example, HHC, ZTE, etc.  Would the sub-types be considered the proprietary names and required to be listed, or would simply listing XYZ as the overall brand suffice when listing in the establishment listing database?

The question is posed because management wishes to keep the sub-type names confidential.  I have advised that the option to make each confidential is available, but they would like to explore the possibility of listing only the overall brand, and not all the proprietary names for the various device types.

Hope this is clear.


Thanks much, and happy Friday!


Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Hi Laura,

Something else to consider is if your product sub-types differ from each other at all in terms of ingredients or other characteristics; I'm not sure if device listing has all the same requirements as drug listing, but when we list drug products, we need to list each strength associated with a particular product name so that all the characteristics of the product, in all the forms it may take, are captured in the listing. 

Hope that helps,
Courtney

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Courtney Portik
Atlanta, GA

------------------------------

Original Message:
Sent: 16-Mar-2018 13:56
From: LAURA HOSHUE
Subject: Establishment listing - Proprietary names (or brand names)

Fellow colleagues,

Hope all is well.  In reading the regulations, it seems that proprietary names and brand names are used interchangeably.  While the FDA recommends that we list all proprietary names under which a device is marketed in the US, it also states that at least one proprietary name or brand name be listed.

I interpret it to mean that say we sell condoms under the overall brand XYZ, but under that brand we have several condom sub-types, example, HHC, ZTE, etc.  Would the sub-types be considered the proprietary names and required to be listed, or would simply listing XYZ as the overall brand suffice when listing in the establishment listing database?

The question is posed because management wishes to keep the sub-type names confidential.  I have advised that the option to make each confidential is available, but they would like to explore the possibility of listing only the overall brand, and not all the proprietary names for the various device types.

Hope this is clear.


Thanks much, and happy Friday!


Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------