Definition Medical Device Accessory - FDA Definition of Accessory

[Sheppi76]

I am looking for some assistance in regards to the FDA?s medical device regulation and definition, and to be more specific, the definition of an accessory of a medical device.

I work for a company that manufactures products that are used in the dental industry. Some of our products, I am very clear that these are in fact medical devices and therefore regulated. However, a large number of the products we manufacture and sell, I have difficulty in determining if they are a product that should be regulated as a medical device. Over the years, the company has just said in general, across the board, "if it is used in a dental office, it's a medical device" because if the product itself is not a "device" it must be an accessory and then. As this seemed the best way (simplest) to address all medical device regulations on a global basis. And they have proceeded to manufacture, handle, register, etc ALL of their products as medical devices.

Now as we prepare for the upcoming device tax to begin in 2013, the company is rethinking this, as they have now noticed, is that if the device is listed, then we will be paying the tax on it. However, if the product is not a device, it should not be listed and then there should be no tax on it. And we have also noted, that of similar products available on the market, they are not listed with the FDA.

Can someone please let me know their thoughts/advice on this and some assistance in clarifying the definition of and accessory to medical device. This would be very helpful to us in moving forward with making that determination of if these products are supposed to be listed or not.

(here are some examples of our products:
Set-up Trays/Tubs ? these trays are used to hold and transport the dental instruments/supplies that are used during a dental procedure to and from the operatory, this is very similar to the tray you get at any local fast food place or cafeteria to carry your food back to your table, the only difference is it is for dental offices.
Shelf (and accessories) ? this is a shelf that can be mounted in the operatory to hold equipment supplies, and the accessories are for how it will be mounted (on a cabinet, light pole, wall etc).
Denture and Retainer Boxes ? these are the boxes the end-user can use to hold/store dentures and retainers in when they are not in use.
Sterilization Cassettes/Containers ? these are products that hold the instruments during cleaning and sterilization. They only hold the devices, they do not maintain any sterilization (wraps and pouches are used for this
Racks ? These are racks that just hold and organize the trays/tubs/cassettes/containers when they are not in use)

 

[MIREGMGR]

Re: FDA Definition of Accessory to a Medical Device - assistance please

My take is that FDA has no consistency regarding formal definitions and the legacy body of regulations and product code definitions.

Unlike the EC, the FDA doesn't have a coherent definition of what an accessory is. The word "accessory" appears inclusively in several regulations and product code definitions, but not in others even though implied.

So: if your object is close enough to something that the FDA has assigned a Product Code, it's regulated. If it's not, and it doesn't contact the patient, and there isn't another confusing circumstance, maybe it's not regulated.

But good luck in making an argument based on this to the IRS. My expectation is that their stance will be: We only use FDA definitions when they work well, and in this case we use the following definition: if it's marketed by a company that markets at least one medical device, it's subject to the tax, and you may try to convince us otherwise but any such argument will be considered in a guilty-until-proven-innocent context.

The company for which I work has the same problem, so I'm sympathetic.

 

[Sheppi76]

Re: FDA Definition of Accessory to a Medical Device - assistance please

Thanks for your reply. It's pretty much what I am expecting for responses, but I figured. I'm much just searching as much as I can and documenting what I am doing, trying to do all I can to show due diligence how we can jusfity whether a product is a device or not.

It will also be interesting next year how the IRS will be addressing this then how they are doing this tax.

For how you explain it, would you also be suggesting then, that the IRS is not just going to use the info they have obtain from the FDA, but they are also looking at the products that have never been listed with FDA that are similar to products listed with the FDA? If they don?t, I?m curious as to how they enforce a tax a product just because it was listed at one time (this is saying if we were to remove listings that we ultimately decide to NOT be a medical device), but then also explain that they are not taxing the same device because it was never listed with the FDA (our competitor products that are not listed).

 

[MIREGMGR]

An internal argument similar to yours has been floated with our Controller, who has done one seminar so far on what's known of how the law will be applied.

His view is that we will not be trying to cut out or change the status of any borderline products, because he doesn't want to sit through any audits with the non-medical-expert IRS folks who will be handling this. His expectation is that they will expect a formal statement from FDA or formal opinion from our law firm as to non-applicability, and if not convinced can be expected to apply the quite daunting penalties for intentional avoidance, at which point we would have the unpleasant financial Hobson's choice of paying the penalties or going to court.

 

[geneticgem]

Just FYI: I am also in the dental business and the sterilizer cassette is a class II device that requires a 510k and has a guidance document for the testing requrired.

 

[Katalina]

Shelves and racks are not devices. Denture/Retainer boxes are not devices. The set-up trays do not sound like a device unless it is something reusable that gets sterilized between patients. As the other commenter said, sterilization cassettes are definitely devices and require a 510(k), so if you are making and selling them and don't have a 510(k) for them and are not listing them, you will have a problem in an FDA audit. See product code KCT on the FDA device listing website.

 

[KenRohler]

Re: FDA Definition of Accessory to a Medical Device - assistance please

My take is that FDA has no consistency regarding formal definitions and the legacy body of regulations and product code definitions.

Unlike the EC, the FDA doesn't have a coherent definition of what an accessory is. The word "accessory" appears inclusively in several regulations and product code definitions, but not in others even though implied.

So: if your object is close enough to something that the FDA has assigned a Product Code, it's regulated. If it's not, and it doesn't contact the patient, and there isn't another confusing circumstance, maybe it's not regulated.

But good luck in making an argument based on this to the IRS. My expectation is that their stance will be: We only use FDA definitions when they work well, and in this case we use the following definition: if it's marketed by a company that markets at least one medical device, it's subject to the tax, and you may try to convince us otherwise but any such argument will be considered in a guilty-until-proven-innocent context.

The company for which I work has the same problem, so I'm sympathetic.

I too am confused as to what constitutes an accessory in the FDA medical device listing. We make medical tables and chairs. In our DHF we list all the removable parts like arm rest or extensions that are included with the device.
Do we need to list in the FDA device listing site or need a DHF for accessories that are options sold in addition to the base unit but should not be considered a standalone medical device e.g. table top pads or foot controls?
Does the FDA define what should be included in the device listing?

 

[MIREGMGR]

Re: FDA Definition of Accessory to a Medical Device - assistance please

Do we need to list in the FDA device listing site or need a DHF for accessories that are options sold in addition to the base unit but should not be considered a standalone medical device e.g. table top pads or foot controls?

My take is no.

Does the FDA define what should be included in the device listing?

They will say yes. I say not really.

In the context of this overall thread, my answer would be: a device option that's not offered for independent purchase is neither a device nor an accessory. A device option that may be purchased either in combination with the underlying system or device, but that if purchased independently does not perform a device-definition task or function by itself, is an accessory and is not a device. A device option that may be purchased independently and if so purchased and used by itself or in some combination can be used to perform a device-definition task or function is itself a device.

And, IRS doesn't really use the FDA's definitions even though they say they do, and instead considers all of the above to be devices for purposes of establishing sales subject to MDET.