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Calling a medical device a medical device (when it might not be one..)

James

Involved In Discussions
#1
Hi

I'm just wondering about the implications and/or costs or benefits of calling a product a MD if it is perhaps more accurately not a medical device but a general consumer product?

I am thinking in particular of a software application that we have developed and we have placed on the market (albeit we do not charge for its use). It is software, which helps parents to make decisions about whether their baby is unwell. It isn't diagnostic (in my opinion) but it is 'informative'.

It would be useful to get some thoughts from the forum

Thanks

James
 
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James

Involved In Discussions
#3
Well, if it is a medical device, then you are subject to regulation regardless of whether or not YOU call it an MD, or whether or not you charge for it.
Thanks for your contribution. However, I'm fairly sure that you are wrong. The claims made by the manufacturer are paramount in determining a devices status, and it would ultimately be for the courts to rule otherwise.

If it is not an MD but you call it an MD, then you are improperly (falsely?) advertising it.
No, not if the claims we are making are upheld by the courts. If an item is blatantly a MD and the opposite is being claimed, then this of course would initiate swift regulatory action; for example if i was trying to sell the shoddy heart pacemaker I made in my shed as a wellness and lifestyle product :)

Thanks, that's useful information. It seems fairly vague, but I've not delved right into it yet. Also, just because a medical device is a medical device in one jurisdiction doesn't mean it will be in another. We have similar UK guidance, albeit the framework is under revision. The big question for me with the device I'm questioning is "what does 'diagnostic' actually mean in a MD regulatory context?"

3 examples to illustrate this:
1. Some software, based on its input data and functionality, is able to DIAGNOSE a condition. This is medical device
2. Some software asks users some questions, and predicts on the basis of the answers that the user 'MAY' have a condition, but clarifies that a Physician and further formal diagnostic tests need to take place in order to confirm this. I would categorise this as a medical device (as I suspect would UK regulators), but the courts may rule differently should they become involved.
3. Some software asks users some questions, and predicts on the basis of the answers that the user should get further input from a Physician to form a diagnosis. Is this software as a diagnostic medical device?? I think not, and I think the manufacturer could justifiably state this in their claims. The regulator isn't sure. Claims could be challenged in either direction. The courts would ultimately decide (if they got involved).
 

James

Involved In Discussions
#5
It has nothing to do with calling it anything. It comes down to what you say (Claim) the device does or doesn't do.
I think the wording in my original post was sloppy (I was rushing). instead of 'calling' it, I would say 'classifying' it, which is of course associated with its claims. The 'claims' introduce a new set of issues, as per my 3 theoretical examples. Have you seen a clear definition of 'diagnostic' in a regulatory context Ed?
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#7
I understand you want to keep the product anonymous. I'll ask a more basic question: Could the use of your "Device" impact the actions a user would take in regards to their or another's health?

the FDA in warning letters often uses the phrase:

"intended for use in the mitigation, prevention, treatment, diagnosis, or cure of xxx disease"

If you are unsure review what FDA states in warning letters here:

Warning Letters | FDA

From CDRH and see if you have strong answers to these types of accusations.

Also, is this device related to COVID-19? FDA is really slamming devices with any mention of COVID-19 to prevent taking advantage of the crisis.

If you are still unsure search the 510(k) database for devices similar to what yours claims...

510(k) Premarket Notification (fda.gov)
 

dgrainger

Trusted Information Resource
#8
This appears to be a diagnostic device and could be class IIa as it appears to allow direct diagnosis (baby is unwell/not unwell).

MHRA has recently changed it's view on intended use. They will look at what the consumer believes the product is intended to be used for:

"Based on the surrounding circumstances e.g. the labelling, instructions for use, promotional material, its mode of action and manner of use as perceived by the consumer, it is possible for an objective observer such as the MHRA or an averagely informed consumer to view the product as a medical device."

It's from a compliance case looking at baby monitors:
Medical devices: information for users and patients
 

Nisha

Starting to get Involved
#9
The classification of the device is based on Intended Purpose or use of the device or claims you are targeting on the product.
Here is a link guidance on SaMD (Software as medical device including apps) from MHRA:
 
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