Is it Legal for Printing CE Mark in Label? FDA Aspect

[wangyang]

Dear all:

Our product is going to be sold to both FDA and Europe. And my boss want to use the same labeling for both the 2 areas. However, is it legal to attach the CE-mark and the address of the Europe representative on the label, according to FDA's regulation?

 

[Alexisss]

Re: Is it legal for printing CE-mark in label?

As long as you clearly show who is your "European Authorised Representative", you will be ok for Europe.

If you also satisfy the FDA requirements, they I evaluate that u will be fine.

 

[MIREGMGR]

Re: Is it legal for printing CE-mark in label?

The FDA has no problem with the (appropriate) presence of the CE Mark.

 

[bio_subbu]

Dear all:

Our product is going to be sold to both FDA and Europe. And my boss want to use the same labeling for both the 2 areas. However, is it legal to attach the CE-mark and the address of the Europe representative on the label, according to FDA's regulation?

There is no prohibition against adding the CE mark or other markings to a device or its packaging. As long as the information required by the FDA is included on the label and the label does not contain any false or misleading information, additional information, such as CE marks or “ISO xxx compliant,” can be included on a package or product label. Additionally, the CE mark is fairly well recognized in the U.S. The information required by the FDA is below:

Subpart A--General Labeling Provisions

Sec. 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.

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

b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for "Company," "Incorporated," etc., may be used and "The" may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.

c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, "Manufactured for ___", "Distributed by _____", or any other wording that expresses the facts.

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).

e) If a person manufactures, packs, or distributes a device at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such device was manufactured or packed or is to be distributed, unless such statement would be misleading.

Additionally, the FDA recognizes selected symbols in the standard EN980:

Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

Below are some links to some other guidance’s regarding product labeling:

Labeling Regulatory Requirements for Medical Devices

Guidance on Medical Device Patient Labeling

Device Labeling Guidance #G91-1 (blue book memo)

Hope you find this information helpful.

Regards
S. Subramaniam

 

[Alexisss]

For Europe, I am not sure that it is ok to print on the product "ISO XXX compliant" or anyway similar standard-complying expression.

This is because one (especially a layman) may be mislead to believe that the product is of X quality of Y type, whereas the standard may only partially applied.

Also, for the application of CE mark the product will probably be complying/have been tested for compliance with more than one standard.

It is funny some even print "ISO 9001" on the label!

I would advise to stick to FDA marks and CE mark.

 

[sreenu927]

Hi..

As suggested above, No problem in using Single label for multiple markets.

It's cost and efforts saving if same label is used for various markets (Single Instrument-Single Label strategy).

Regards
Sreenu

 

[Tiffany]

Hi mates,

How about to print the wording " FDA Approved" or " FDA Cleared" on the outer box of the product? Is that legal? Which part of the FDA mentioned about this?

Can the manufacturer do so as this is for advertising purposes.


Tiff

 

[MIREGMGR]

How about to print the wording " FDA Approved" or " FDA Cleared" on the outer box of the product? Is that legal?
Can the manufacturer do so as this is for advertising purposes.

Bad idea, no, and no.

Which part of the FDA mentioned about this?

This is discussed multiple times in rules and guidances, but for instance, see page 4 at http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM095308.pdf.

 

[Big Jim]

There is no prohibition against adding the CE mark or other markings to a device or its packaging. As long as the information required by the FDA is included on the label and the label does not contain any false or misleading information, additional information, such as CE marks or “ISO xxx compliant,” can be included on a package or product label. Additionally, the CE mark is fairly well recognized in the U.S. The information required by the FDA is below:

Subpart A--General Labeling Provisions

Sec. 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.

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

b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for "Company," "Incorporated," etc., may be used and "The" may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.

c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, "Manufactured for ___", "Distributed by _____", or any other wording that expresses the facts.

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).

e) If a person manufactures, packs, or distributes a device at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such device was manufactured or packed or is to be distributed, unless such statement would be misleading.

Additionally, the FDA recognizes selected symbols in the standard EN980:

Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

Below are some links to some other guidance’s regarding product labeling:

Labeling Regulatory Requirements for Medical Devices

Guidance on Medical Device Patient Labeling

Device Labeling Guidance #G91-1 (blue book memo)

Hope you find this information helpful.

Regards
S. Subramaniam

It is not appropriate to use the ISO 9001 markings on the product, product packaging, or certifications. This is an ISO requirement that is expected for the CB to police.

I have attached an ISO publication on the topic. It is a little old as it is still about ISO 9001:2000, but the requirement has not changed.

Think about it for a moment. What is certified is the quality management system. Adding such markings to the product can be misleading to make it appear that the product is certified and it is not.

 

[bio_subbu]

Hi mates,

How about to print the wording " FDA Approved" or " FDA Cleared" on the outer box of the product? Is that legal? Which part of the FDA mentioned about this?

Can the manufacturer do so as this is for advertising purposes.

Tiff

According to FDA Device Labeling Guidance #G91-1 (blue book memo) any representation that implies official FDA approval for an exempt or FDA cleared product is misbranding: please refer below

Regulations applicable to medical devices provide that the inclusion of any of the following representations in device labeling constitutes misbranding of the device:

21 CFR 801.6 - False or misleading representation with respect to another device or a drug

21 CFR 807.39 -Any representation that creates an impression of official approval because of registration or (e.g., inclusion of FDA establishment registration number)

21 CFR 807.97 - Any representation that creates an impression of official approval because of complying with the premarket notification regulations (e.g., inclusion of premarket notification reference number)

XIV. Prohibited Acts

Section 301(1) of the act prohibits the use in any labeling or advertising for the device of any representation or suggestion that approval of an application with respect to the device is in effect under section 515 of the act (premarket approval) or that the device complies with the provisions of section 515.

Advertising and marketing of medical devices are considered to be labeling by the FDA. Anything prohibited in labeling is also prohibited in advertising. For more details refer these FDA guidance documents Device Labeling Guidance #G91-1 (blue book memo) & Labeling Regulatory Requirements for Medical Devices