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Down Classifying a Medical Device from Class II to Class I - Page 3

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  Post Number #17  
Old 21st December 2016, 12:18 PM
Julie O

 
 
Total Posts: 221
Re: Down classifying a Medical Device from Class II to Class I

Quote:
In Reply to Parent Post by Ronen E View Post

Classification and predicates are two separate issues.

Quote:
In Reply to Parent Post by Ronen E View Post

for me ProCode determination always includes looking for that equivalent precedent.

It occurs to me that I am (I think?) the only US-based regulatory professional involved in this discussion. I come back to mindset and perspective, and now will add in terminology and historical habit, along with manufacturing versus product development.

Coming from a US-based product development perspective, when someone starts talking about "equivalent," I take it that they are talking about a predicate, whatever they might choose to call it. The purpose of the predicate is to lead you to the appropriate classification regulation. It would seem the procode is used the same way.

Whether you start with a predicate and eventually identify an appropriate procode, or start with a procode and then eventually identify an “equivalent precedent,” I don’t really see any meaningful difference between the place you end up, which is with the classification regulation and another device that is “similar” to your device. So, maybe not so much two sides of the same coin as two roads to the same destination.


In the US-based product development circles I run in, classification and predicate are not two separate issues. Question 0 is not what is the procode or classification regulation, but what is the predicate. That is because, as you note, identification of a predicate will give you a lot of information that is useful to product development, where identification of a procode or classification regulation gives you very little information.

The procode approach applied to a device that is an exact or perfect match to the procode would seem to be the best fit for the manufacturer of essentially “generic” devices, where competitors make essentially the exact same device, and competition is based on manufacturing cost and quality. I prefer the predicate approach because it gives you the flexibility needed to develop a device that is not the exact same device, but an innovative device, without necessarily having to go the De novo route.

I also find myself wondering whether ex-US regulatory professionals fully appreciate the extent to which the get-rich-quickers mangled the 510(k) process beyond all recognition over the last couple of decades, hopefully terminating with FDASIA. As a US-based regulatory professional, I tend to cringe when I hear that a device is “the exact same” device as another device. So when I hear someone talk about a procode that “perfectly” describes a device, I’m inherently skeptical. “Predicate” is a more comfortable term for me.

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  Post Number #18  
Old 21st December 2016, 08:10 PM
Ronen E

 
 
Total Posts: 3,736
Re: Down classifying a Medical Device from Class II to Class I

Quote:
In Reply to Parent Post by Julie O View Post

So when I hear someone talk about a procode that “perfectly” describes a device, I’m inherently skeptical.
The only one I noticed talking about a "perfect match" between a ProCode and a device in this thread is you.

I don't think I can (or should) provide more elaborate explanations than I already did on the current topics, so I'll leave it at that. I'm not interested in debating who's "more right" when it comes to linguistic contextual subtleties. If your point is that you're right and I'm wrong, then so be it - I'm comfortable with you arguing that I'm wrong in this case. I'm more interested in the question "what is the most effective and efficient process to regulatory clearance of low-medium risk devices?"

Too bad I'm not situated on holy US soil. I guess that disqualifies me both as a US-regulatory specialist and a worthy oponent in this discussion.

Cheers,
Ronen.
  Post Number #19  
Old 21st December 2016, 10:03 PM
Julie O

 
 
Total Posts: 221
Re: Down classifying a Medical Device from Class II to Class I

Quote:
In Reply to Parent Post by Ronen E View Post

The only one I noticed talking about a "perfect match" between a ProCode and a device in this thread is you.

From two separate comments by shimonv:
Quote:
In Reply to Parent Post by shimonv View Post

You don't need a predicate for a class I device; what you do need is a regulation / product code that describes perfectly your device.

Quote:
In Reply to Parent Post by shimonv View Post

It is my understanding that if you meet the exact definition of one of the class I regulation (e.g. 872.6865 for electric toothbrush) then your device is class I by self declaration.

Quote:
In Reply to Parent Post by Ronen E View Post

I'm not interested in debating who's "more right" when it comes to linguistic contextual subtleties. If your point is that you're right and I'm wrong, then so be it.

I must say, I’m quite taken aback at this response. Maybe it’s just me, but when someone talks about “looking at the same coin from different sides,” “two roads to the same destination,” “two approaches,” etc, I think they are doing the exact opposite of arguing “right” vs. “wrong.”

I’m also disappointed. Up until now I was thinking this was the most interesting regulatory discussion I’d had in ages.
Quote:
In Reply to Parent Post by Ronen E View Post

Too bad I'm not situated on holy US soil. I guess that disqualifies me both as a US-regulatory specialist and a worthy oponent in this discussion.

While this comment breaks my heart in so many ways, I can’t even talk about it.

Last edited by Julie O; 21st December 2016 at 11:23 PM. Reason: Omitted a word
  Post Number #20  
Old 22nd December 2016, 12:13 AM
Ronen E

 
 
Total Posts: 3,736
Re: Down classifying a Medical Device from Class II to Class I

I'm repeating myself for the sake of others who might come across this thread in the future:

There's a difference between matching a device with a classification regulation and matching a device with a ProCode, especially when it comes to low risk devices. Classification regulations usually provide a meaningful (sometimes elaborated) definition and many times some useful examples too; while low risk ProCodes (ie those that don't have an associated device-type-specific guidance document) only provide a telegraphic title.
  Post Number #21  
Old 22nd December 2016, 12:53 PM
DCONN1

 
 
Total Posts: 10
Re: Down classifying a Medical Device from Class II to Class I

Thank you everyone very much for the replies and interesting discussion.

In response to Marcelo's question:

Quote:
Why would you need a recall of device which were marketed in compliance with the regulations they should comply?
It seems to me that a market withdrawal/recall for the Class II devices would be appropriate at least for practical reasons if the name of the product remained unchanged. Otherwise, the product would be on the market with two different forms of labeling in terms of the indications for use in the IFU. Technically from a regulatory standpoint they would be two separate products (and would be listed as such on the FURLS device listing, but with the same product name). I'm thinking in more practical concerns for avoiding confusion, but does anyone see any concerns from a regulatory standpoint with not withdrawing the Class II-labeled products from market?
  Post Number #22  
Old 22nd December 2016, 04:52 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,368
Re: Down classifying a Medical Device from Class II to Class I

Quote:
It seems to me that a market withdrawal/recall for the Class II devices would be appropriate at least for practical reasons if the name of the product remained unchanged. Otherwise, the product would be on the market with two different forms of labeling in terms of the indications for use in the IFU. Technically from a regulatory standpoint they would be two separate products (and would be listed as such on the FURLS device listing, but with the same product name). I'm thinking in more practical concerns for avoiding confusion, but does anyone see any concerns from a regulatory standpoint with not withdrawing the Class II-labeled products from market?
I would see a problem with stock, but if you sold all the devices under Class II, and then you begin sell all of them as Class I, I would not think it's a big problem. Surely this might cause a small confusion, in particular for people who bought the Class II one, but I don't think an extreme measure such as a recall would be needed. Anyway, you should probably discuss this with the FDA, for example.
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