FDA proposal on Medical Device Accessory Risk Assessment

Bev D

Heretical Statistician
Leader
Super Moderator
Re: FDA proposal on Medical Device Accessories

I am not sure about this statement, because from the regulations point of view, you need to prove that your mounting trolley is working with another manufacturer device.

by 'prove that...trolley is working with'' do you that it is designed and intended to work with a specific system OR that it actually does work with the system as intended?
 
M

MIREGMGR

It used to be that the relevant Product Code required a 510(k), in which such proof presumably would be expected...although, noting that no such 510(k) ever had been granted so there was no procedural precedent, the then-relevant guidance didn't mention a requirement for such integrative proof because it assumed that the trolley and light system would be from a single maker.

I did directly discuss this issue with the relevant FDA review section head. He was uncertain how they would approach it, and proposed that we would work together on what should be included. He didn't make any mention of our providing proof of integrative functionality; his approach instead seemed to be that he would want an acknowledgement from the light system maker that they were on board with our project (which they were), so that their acknowledgement would serve as an indication of engineering review of those kinds of questions. (Which FDA wouldn't have the engineers or system-functionality understanding to do themselves.)

In any case, the August 1 draft Guidance included the relevant Product Code, so now there would be no FDA review.
 
Last edited by a moderator:

Mark Meer

Trusted Information Resource
My view, and I think FDA's as well, is that such a mounting trolley would be an accessory and subject to some device regulations, but not a device in its own regard.

I apologize, but I'm still confused.

Definitions aside for a moment, if you've determined that a product is an accessory but not a device, what does this actually mean (from a practical point of view)?

For example:
- product A is an accessory (but not a device) with its own procode.
- product B is in the same class as product A, but is a device.

Is there any practical difference between the two in terms of, for example:
- listing with the FDA?
- labeling requirements?
- marketing?
 

Ronen E

Problem Solver
Moderator
I apologize, but I'm still confused.

Definitions aside for a moment, if you've determined that a product is an accessory but not a device, what does this actually mean (from a practical point of view)?

For example:
- product A is an accessory (but not a device) with its own procode.
- product B is in the same class as product A, but is a device.

Is there any practical difference between the two in terms of, for example:
- listing with the FDA?
- labeling requirements?
- marketing?

Mark,

In practical terms it all comes down to the procode, which dictates all the manufacturer's obligations and exemptions. Class helps determine the controls applicable to each procode, however it's a more generalized characteristic and is therefore less useful in determining what exactly you need to do.

Listing and Labeling requirements come under the General Controls and are therefore applicable to all devices and accessories that fall under any procode. It is generally the manufacturer's responsibility to comply, regardless of the FDA's level of actual enforcement.

"Marketing" is a very broad term. It should be broken down to more specific actions in order to determine what specific requirements apply to any given device / accessory.

Cheers,
Ronen.
 

Mark Meer

Trusted Information Resource
In practical terms it all comes down to the procode...

Thanks Ronen, but I'm afraid I'm still confused (maybe a bit thick in the head today...).

What you've described applies regardless of whether determination is made that the item is a device, or just an accessory.

What I'm trying to figure out is, in practical terms, what is the difference?

In otherwords, I've got a product, I lookup the procode and it tells me what's applicable and what's not. ...so does it even matter whether I've deemed the product an accessory or not?
 
M

MIREGMGR

Some accessory-type products don't fit into any procode, even though they're marketed as an accessory to an Exempt or 510(k) device. That's because some procodes say "including accessories and components", but others don't, and some accessories' functions are not clearly consistent with the device definition except in a procedural-proximity sense.

Generally when a 510(k) is submitted and accessories are included, FDA will clear the whole system irrespective of the exact wording of the procode, since there's no other logical course. FDA has no good course, though, when the system 510(k) is already cleared and closed; a new accessory is to be marketed by some other establishment than the holder of the system 510(k); and either the accessory type does not have its own guidance or a guidance for the system doesn't say anything useful about the accessory.

In a situation like this, it's very useful to be able to explain to FDA that the product is an accessory to a cleared device rather than a freestanding device by itself, so that FDA can most quickly decide what clearance path will apply.
 
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