Use of non consensus ISO standards in Marketing Material

[VTARA]

Is anyone using compliance with ISO standards that are not a consensus standard with the FDA in marketing material?

We've got a couple competitors that have started doing it, and I was always told that was a no-no even in marketing material.

 

[MIREGMGR]

The social-policy risk in this situation is not that you conform to a non-standard Standard per se...it's that your marketing communications imply to uninformed, sometimes-eager-to-believe customers that such conformance in some manner says or implies that your product is safe and effective--perhaps more so than competing products or treatment approaches--and that this communication is partly or wholly untrue or at least unproven to FDA's satisfaction, or otherwise regarded by FDA or other authorities as illegal or unfair.

I think the most straightforward way to avoid having FDA come after you in such a circumstance is to avoid such marketing communications.

I've been told in the past that it's quite common for FDA to be provided by members of regulated industry with information and examples of such questionable marketing communications from competitors, and that many FDA actions originate with such received information.

 

[VTARA]

True, other telling so to speak in is from what I've seen the most common way the FDA catches companies.

It's not so much in this case that they're misleading or not complying with the ISO standard, they do. It's that the FDA does not recognize the part of the standard they are using as a marketing claim. The claim they are marking is actually one commonly known outside the US, and is actually something that is in the Regs from the PH side of things. This is one of those cases where what the CDC/AAMI guidelines for practice are not in line with that the FDA recognizes.

 

[Kales Veggie]

Is anyone using compliance with ISO standards that are not a consensus standard with the FDA in marketing material?

We've got a couple competitors that have started doing it, and I was always told that was a no-no even in marketing material.

Do you have an example of an ISO standard that is not a consensus standard?

 

[MIREGMGR]

Do you have an example of an ISO standard that is not a consensus standard?

For discussion purposes, an example would be EN 13795, for patient drapes, equipment covers and surgical garb.

 

[Kales Veggie]

For discussion purposes, an example would be EN 13795, for patient drapes, equipment covers and surgical garb.

I do not think that is an ISO standard.

There is a ISO 13795:

ISO
13795:2012
* Ships and marine technology ? Ship's
mooring and towing fittings ? Welded
steel bollards for sea-going vessels

 

[MIREGMGR]

I don't know the historical reasons for the numbering collision having been allowed.

EN 13795 is referenced here (pdf) on page 9, and has been published in the OJ. My understanding though is that it is very unlikely to be adopted by US FDA, because it was written to promote a material technology offered by a small group of specialized material makers over the most commonly used technology, which is non-proprietary.

 

[VTARA]

The ones I know of are device specific ones. The one that comes to mind the quickest and is causing some major heartache is ISO 11140-1 Sterilization of health care products-Chemical indicators

FDA Choose to recognizes only three of the six classes, Class 1, 2, and 6. One and two are fine, as they're also biggies with the CDC/OSAP...etc. However the practicing world does not like class 6 at all, and really likes Class 4 and 5 which the FDA hasn't included. In fact Canada is now requiring a Class 4 or 5 as in internal CI.

It's really a strange case all around.

 

[Ronen E]

The social-policy risk in this situation is not that you conform to a non-standard Standard per se...it's that your marketing communications imply to uninformed, sometimes-eager-to-believe customers that such conformance in some manner says or implies that your product is safe and effective--perhaps more so than competing products or treatment approaches--and that this communication is partly or wholly untrue or at least unproven to FDA's satisfaction, or otherwise regarded by FDA or other authorities as illegal or unfair.

I think the most straightforward way to avoid having FDA come after you in such a circumstance is to avoid such marketing communications.

I've been told in the past that it's quite common for FDA to be provided by members of regulated industry with information and examples of such questionable marketing communications from competitors, and that many FDA actions originate with such received information.

Is there any written reference to this policy? Sounds a little like a restriction of freedom of speech. After all, I assume the devices DO comply with those non-recognized standards (otherwise it's fraud), and such subtle implications would at least be subject to debate on the basis of the actual marketing materials wording, wouldn't they?... Again, if there are blunt statements re. safety and efficacy based on such a standard - that's one thing, but otherwise... After all, if these products are duly cleared by the FDA then the FDA must have been satisfied that they ARE safe and effective (or at least has no reason to conclude to the contrary).

 

[MIREGMGR]

My observation from reading the weekly Warning Letter bulletins for a number of years now is that almost all of FDA's unproven claims/misleading marketing actions are in relation to either Class I devices, devices that require clearance but haven't been submitted, or devices of types that FDA is unwilling to allow on the market.