Down Classifying a Medical Device from Class II to Class I

DCONN1

Starting to get Involved
#1
I have a question about what is perhaps a unique situation involving shifting classification of a device from Class II to Class I. My apologies, as this may be very difficult to explain without giving specifics;

A company owns a device which was cleared via a 510(k) submission. It was determined to be a Class II device based upon its indications for use, which encompassed a "general" use as well as an additional "specialized" use. Many years subsequent to clearance, the company decides that it would like to market the product with only the general use indications and drop the specialized use indication. This decision is made not based upon risk management concerns; the company makes this decision based upon the fact that this product is being used on the market exclusively for the general use indications, with the market for the product being used for its specialized indications being negligible to non-existent.

By marketing the product without its specialized indications, the device would be classified as Class I; it is only the inclusion of the specialized indication which causes it to be classified as Class II. As a benefit, by marketing the device without its specialized indication and thus re-classifying as Class I, the company can potentially greatly reduce the regulatory burden in countries around the world which use an FDA-equivalency registration pathway.

My questions are:
- Is this down-classification allowed to be done under the regulations? Is there any formal procedure involved other than internal documentation and listing the product on FURLS as a Class I device?
- I would assume that the company would need to recall the product on the market with labeling which includes the specialized indications for use. Would there be any other potential significant downsides to doing this?
 

JeantheBigone

Quite Involved in Discussions
#2
A down-classification is certainly possible, the question is what effort is required.

Any change in indications for use or labeling triggers the need for a modification 510(k). Especially a down classification, since the controls are less restrictive.

The only way I can see not needing a 510(k) is if the downclassified device is not only Class I, but Class I exempt AND there is nothing about the device or its intended use which trips the limitations of exemption.

I would avoid the use of the term "recall" and see if you can retrieve the product under a "market withdrawal."
 

Ronen E

Just a person
Super Moderator
#3
Alternatively, look at the downclassified device as a new device. Clear the new device based on its new ProCode's requirements (I would conspicuously highlight in the labelling that the "special" indications are not covered, to remove doubt). The old device can be either collected or left in the market provided that you maintain related obligations until the last unit issued with the old indications expires (there might be related record keeping requirements that go years beyond discontinuation, though).
 

shimonv

Quite Involved in Discussions
#5
What will serve as the predicate for the Class I device?
Hi,
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. If you have a product code you can do a search for class I device with the same code and thus make a better argument or increase your own confidence.

Shimon
 
#7
Hi,
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. If you have a product code you can do a search for class I device with the same code and thus make a better argument or increase your own confidence.
Shimon
You say you don't need a predicate, but then you seem to go on to describe a process for finding a predicate?

If the procode is really appropriate to your device and if you can find a class I device with the same code, then that device will serve as your predicate. You must then demonstrate that your device is substantially equivalent to the predicate. This is true even if your device is 510(k) exempt.

(A device that is 510(k) exempt is exempt from the requirement to submit a 510(k) notification to FDA, but not from the need to show SE; otherwise, you don't know if the device you want to use as a predicate is actually suitable as a predicate, which means you don't know if your device really falls under the same classification regulation as the device you want to use as a predicate, which means you don't really know the classification of your device.)

If you can't find a predicate for your device (whether by using a procode or some other method) then, as far as I know, it is a novel device and you must submit a De novo petition to ask FDA classify it. FDA will then determine the classification of your novel device, assign it a new procode, and issue a new classification regulation that describes it.
 

shimonv

Quite Involved in Discussions
#8
Hi Julie,
To the best of knowledge and familiarity with FDA guidance documents, predicate devices and substantial equivalence are terms exclusive to class II devices; they are not applicable to class I or class III devices.

As for product codes - each is associated with one device class.
When it comes to class one devices (e.g. electric toothbrush or liquid measuring cup) - their design if fairly simple and intended use is very specific. 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.
Of course, you could do a search on similar class I devices in the market and even do a thorough comparison ('substantial equivalence') but its only comparing your self-declaration to someone else's self-declarion. It has limited value.

Hope it is helpful. Let's see what the rest of the forum members has to say.

Shimon
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#9
To the best of knowledge and familiarity with FDA guidance documents, predicate devices and substantial equivalence are terms exclusive to class II devices; they are not applicable to class I or class III devices.
There are some Class I devices which requires 510K, in this case they would require a predicate device to show SE.

The predicate (and SE) is related to the pre-market notification. Devices exempt from 510K are not required to show SE.
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#10
- I would assume that the company would need to recall the product on the market with labeling which includes the specialized indications for use. Would there be any other potential significant downsides to doing this?
Why would you need a recall of device which were marketed in compliance with the regulations they should comply?
 
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