Manufacturer Name on Private Brand Labeling

[Java23]

Hi,

I need some direction regarding labeling requirements for Private Brand OTC Class II medical device.

We are the legal manufacturer - own the 510(k) and label the product with the private brand name.

My understanding is that we(legal manufacturer) need only state on the labeling
Manufactured for XXXXXXXX or Distributed by XXXXXXXX and there is no requirement for us (legal manufacturer) to put our name on the product.

There has been discussion that some feel the manufacturer, according to IEC 60601 must have their name on the label.

I have not found anything which states that the manufacturer must have their name on the label so long as we are clear by stating "Manufacturer for" or "Distributed by".

Your help/input would be greatly appreciated.

 

[Thordi]

Hi,
as you are responsible for the product on the (US) market, you need to add your adress on the label. All requirements due to complaints and post market activies are under your responsibilities.

The term "Manufactured for" is used, when the legal mannufacturer has an outsourced manufacuring line (OEM model).
Hope this coveres you question,
Kind regards,
Thordi

 

[Java23]

Thordi,

Thank you for your reply. I should have been more clear.

Legal Manufacturer is overseas - and has a couple of plants (part of the same company) that does the manufacturing. Those plants are registered as contract manufacturers.

Am I correct in thinking that we can state:

Manufactured for XXXX (the name of the legal manufacturer)

(no address will be listed - they can be found on the web)

Distributed by XXXXXXXX (this is the Private Brand company)
address
web etc.

Hoping this is a bit more clear.

Thanks in advance for your help.

 

[belemsanchez]

Regarding this thread, I want to talk about EU, MDD 93/42/EEC, where it's only accepted "Manufacturer" or the black factory symbol, and not "Manufactured for", so how is posible to get a label of both markets?
Thanks

 

[Java23]

Hi - I am not aware of any approved symbol for "Manufactured for".

The approved global symbols can be found in ISO 15223. This is the standard I refer to when apply symbols.

Hope this helps.

 

[JeantheBigone]

Let's go straight to the regulations. Since you mention FDA I assume you mean this is a product distributed in the US.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=801.1

"The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor."

etc.

I don't see how IEC 60601 can override FDA. IEC does not have authority to enforce anything. When testing is done to IEC standards, the labeling is reviewed, correct? And labeling is also reviewed when the 510(k) is cleared. So if manufacturer or distributor changes, that information can be swapped out on the label that was originally part of the testing / submission.

 

[Java23]

Jean,

Thank you so much for your input - I guess I wanted to hear that someone other than myself also believed that the CFR was what we need to adhere to.

My feeling is that we don't need to state anything other than.....

Distributed by (name of retailer) or Manufactured for (name of retailer) and of course state the country of origin.

Drove myself nuts trying to find where IEC 60601 stated that the manufacturer name and address needed to be on the labeling.

Thank you so much for your input / advice - Much appreciated!

 

[JeantheBigone]

Glad I could help!

An address is also needed and judging by the way the reg is written, it sounds like FDA insists on a US address:

"(d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice)."

As I read this, if the device is manufactured outside the US, a country of origin is required along with full name and address of a US distributor in order to be in compliance with 21 CFR 801.1

 

[Java23]

You were very helpful

Let's see if you and I are on the same page LOL!

So - product coming from Overseas - label will show:

Distributed by XYZ Company (retailer)
12345 Device Street
Any town, USA 54321
www.xyzcompany.com

Made in Vietnam

Does that look right to you?

Our headquarters is the Legal Manufacturer - they contract out to one of our plants - our plant ships to us in the US and we ship to the retailer.

All of us are the same company (except retailer) but the plants are the "contract manufacturers" and build to the Legal Manufacturer specificatons/510(k).

I really appreciate your comments and insight.............love the learning that takes place here - so glad the Cove came back - when it was shut down for a while I was lost ... just happened to look online yesterday and found it to be back up and running - Hooray. thanks again -

 

[Ronen E]

There is some confusion here.
The "legal manufacturer" is the one holding the regulatory responsibility. In OEM/OBL settings this is typically (ie almost always, the exceptions are quite special cases) the distributor / brand owner, ie the entity placing the device on the USA market.
The contract manufacturer is the immediate entity that supplies finished devices to the brand owner. How it is organised internally / geographically / administratively doesn't matter.
Who owns the design / the 510(k) changes little for the above.
Country of origin statement is a separate issue from specification of name and street address of the regulatory responsible organisation.

Of course 60601 can't override the FDA (or any other regulatory regime). I thought that the question revolved around how to comply with 60601, without going into why you needed to comply with it. It was a premise that you do, for some obscure reason. Some countries adopt certain standards as mandatory in certain situations. I don't see myself as a 60601 expert so I didn't think I should comment about its applicability in the USA or about its labelling requirements.