Guidance on Marketing Devices with a 510k Pending

[EmiliaBedelia]

Hoping for some help from any RA people with a photographic memory for FDA guidance documents....

I distinctly remember a guidance document that had a very specific paragraph that described how devices can be marketed/promoted while they are under review in a 510k. I remember this because it specifically stated that new devices under review can be displayed with a statement that they're pending 510k and not available for sale, but existing devices being submitted for a new indication cannot be promoted for this indication, because essentially you can't stop someone from going out and using the device for that use. I used to use this guidance all the time to keep people from saying stuff they shouldn't, but I can't find the reference anymore! There are several guidances/compliance policy guides that cover this topic and essentially say the same thing, but not explicitly. They are pretty clear to me as RA, but... it's not as good as something from the FDA.

I am looking for this specific guidance reference. The best I can find is an MDDI article (https://www.mddionline.com/regulato...roved-medical-devices-according-to-fda-policy) that talks about the same situation, but I am certain that at one point in time there was an FDA document about this.

If nothing else, I hope that someone else remembers this same document and can at least affirm that I'm not making it up!

 

[Ed Panek]

“Although a firm may advertise or display a device that is the subject of a pending 510(k) — in the hope that FDA will conclude that the device is substantially equivalent — a firm may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use." Thats what I found.

The Spirit of the regulation is "You cant effectively alter a patient's treatment plan by suggesting that if they wait, a better solution is coming. That results in possible harm to the patient since you have not been and may never receive clearance for the submitted devices intended purpose."

 

[Nichole F]

Ed is correct but here is a link to the official Compliance Policy Document if you need a specific reference

 

[EmiliaBedelia]

Yes, I have that one.... I am distinctly remembering a guidance document besides the CPG that "rephrases" that in more detail with specific discussion on new devices vs. existing devices.

I'm thinking the one I am remembering must have gotten taken down with FDA's reorganization of their website, just hoping to confirm for my sanity that it was actually a real guidance document and that I'm not AI hallucinating something from years ago.

Again this document makes 100% sense to me.....but I'm not the person I'm trying to convince.