CE and FDA Mark on same IVD/Medical Device Label

[fondantcookie]

Hi all..

Quick question; I'm getting myself in a tizz...

Is it possible to have an IVD/Medical Device with both the CE mark AND the FDA mark on the same label?

Assuming you have met the necessary MEDDEV/IVDD/MDR/IVDR requirements for CE and relevant FDA requirements.

(it's been a long day and my head is about to implode; think I'm reading too much into this)

Huge thank you in advance

 

[yodon]

Um, there is no FDA mark.

You can have the CE mark on devices distributed in the US (presuming you have appropriate FDA clearance to market).

 

[Ronen E]

It is forbidden to make representations or imply that the device is approved by FDA or the likes, unless it was the subject of a successful PMA.

I usually advise to avoid any use of the FDA logo in device labelling.

 

[fondantcookie]

So IF a product has been through a successful PMA and has met the requirements of the MEDDEV, you can then technically put the CE mark and FDA logo on the same label? And market it within the EU and the US?

This isn't something we are looking to do I'm just enquiring from a knowledge perspective about how it all works.

Cheers

 

[pkost]

you can have a single label that is suitable for both US and EU markets

The FDA will not stop you having a CE mark on your label; there is no equivalent US mark for the EU to object to.

I would avoid putting the FDA logo on your product (even for sale in the US); it is meaningless at best and a regulatory risk at worst

 

[fondantcookie]

Thanks for that

The reason I was getting in a tizz was because at my last company (based in the UK) we went through a successful FDA PMA and updated the labels to state "FDA" approved... I think more as a marketing decision rather than a requirement.

 

[Ronen E]

Thanks for that

The reason I was getting in a tizz was because at my last company (based in the UK) we went through a successful FDA PMA and updated the labels to state "FDA" approved... I think more as a marketing decision rather than a requirement.

I think that in that case it was OK to state "FDA approved" however I would still refrain from using the FDA logo in that statement. They just don't like manufacturers doing it (to say the least).

 

[yodon]

Just a quick follow-up. Here's a link to a page on the FDA website that addresses this: https://www.fda.gov/forconsumers/consumerupdates/ucm047470.htm

As Ronen noted, use of the FDA logo would not be wise - the above article indicates that it may be a violation of federal law.

 

[DEVigil]

It is not OK to indicate "FDA approved" - this is considered misbranding according to FDA guidance. See HHS Publication FDA 89-4203 Labeling Regulatory Requirements for Medical Devices (go to the section starting on page 4 entitled False or Misleading Labeling, particularly the second paragraph).

 

[Ronen E]

It is not OK to indicate "FDA approved" - this is considered misbranding according to FDA guidance. See HHS Publication FDA 89-4203 Labeling Regulatory Requirements for Medical Devices (go to the section starting on page 4 entitled False or Misleading Labeling, particularly the second paragraph).

That's a pretty old guidance. I think they've changed the rule for PMAs in particular, not so long ago actually, but I'll have to dig up a little to get the actual source. When you think of it, a PMA is actually an approval, while 510(k)s, IDEs etc. are not.