Classification of Medical Device Accessories

M

MIREGMGR

#11
When FDA trained me as a 3rd party 510(k) reviewer, they emphasized that the 513(g) is only their opinion at that time is not a final decision. The final decision on classification is the 510(k). For sure a 513(g) helps, but is no guarantee.
That may make sense for a maker of Class II and III devices that is trying to determine whether it should initiate an expensive PMA process, but with all respect to your FDA instructor, it's hardly a sensible stance for a maker of Class I and II devices.

The latter is likely to be using the 513(g) process to verify that a device may be considered Exempt. After a device maker's due diligence and best effort to follow all the available classification procedures, FDA as a matter of political/legislative relations certainly would not want to issue a 513(g) "opinion" to that effect, then walk it back at some later date and penalize the device maker for mis-classification. In the case of a 513(g) process pursued so as to ascertain the proper classification of an Exempt device, there would be no 510(k) process to provide a superseding or final determination. The 513(g) action would have to be definitive assuming provision by the applicant of sufficiently complete and correct information.

513(g) is FDA's implementation of the section of the FD&C Act that states "(...) the Secretary shall provide such person a written statement of the classification (if any) of such device (...)". I don't know that the 513(g) process has been tested in court, but I'd guess that a legal defense or counter-action that a device maker had constructively relied on a 513(g) response on the basis of the above law-provision would be upheld.
 
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Ronen E

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#12
My interpretation on the FDA side (i.e. not MDD)...or maybe wild guess, since I don't know of any written guidance and the verbal interactions I've had with multiple persons at FDA over the past couple of years have been highly inconsistent...is that if a product-to-be-classified is use-specific to a single device or a family of closely related devices from the same maker, and the product-to-be-classified is made or offered by the same maker as the devices for which it is use-specific, then that product-to-be-classified may be an accessory to the devices for which it is use-specific...unless it is subject to a regulation and Product Code that particularly encompasses its type and use, in which case who knows.

The two points of importance, I think, are:

1. On the FDA side, a product-to-be-classified cannot be an accessory to a device for which it is use-specific unless it is made or offered by the same maker as the devices for which it is use-specific. That's because the 510(k) system has no provision for an accessory-to-a-device to be cleared except as part of the 510(k) process for the superior device. If you submit an accessory by itself it must be classified according to its own characteristics, and most accessories don't have the same core function as the device for which they are an accessory.

This of course allows for the common instance of a superior-device maker buying another device to include with (or offer for use with) the superior-device as an accessory.

2. A product-to-be-classified that may be used with more than one superior device, and particularly may be used with superior devices from more than one maker, cannot be an accessory unless it is offered as above by the superior-device maker. There would be no logical way to require such a product-to-be-classified to be incorporated into a superior-device 510(k) that was submitted by an unrelated company, unless that unrelated company voluntarily wanted to include the device-to-be-classified as an accessory.

Thus a product-to-be-classified that is of a type that might be considered to be an accessory, but is made and marketed by a third party and not offered as an accessory by the superior-device maker, must be classified other than as an accessory.

The definitive way to determine the classification of a device, of course, is to file a 513(g).
From the above, and my understanding of the two systems, I now realize that the FDA and EC intents behind "Accessory" may be very different. Actually, the FDA's Accessory may be more in line with the EC's Component (or System member).

In my understanding the logic is pretty simple. It all comes down to whether an item is offered for sale and use independently. If not, it must have been scrutinized and covered to an adequate degree together with / as part of the parent item. Otherwise, it must be somehow cleared on its own. In the EC system, "on its own" means it's either a Medical Device, or an Accessory (treated the same) or non of the above.

The FDA doesn't clarify the issue to the same degree. If an item is not cleared as part of a device (i.e. offered for sale only separate from any other device), it must be somehow classified under some ProCode. Whether this ProCode carries a "Device" or an "Accessory" tag matters little. If the item doesn't fall under any existing ProCode, but does fall under the Medical Device definition, a 513(g) should be the way to go. If all the above hold, and it also doesn't fall under the Medical Device definition, there is currently no clear regulatory provision that I'm aware of that would render it "an Accessory". The definition simply doesn't exist in this system. In the latter case, I guess the FDA's Medical Devices regulatory framework just doesn't apply to the item. I know it's a scary conclusion but it's kind of inevitable if we try to follow a rational approach. The enforcement reality may be different, but that's just arbitrary inconsistency IMO, in the current scheme of things.

Cheers,
Ronen.
 
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