FDA proposal on Medical Device Accessory Risk Assessment

somashekar

Staff member
Super Moderator
#1
FDA proposing to regulate medical device accessories based on the risks they present when used as intended with their parent devices and not based on the risks of their parent devices. For example, if a parent device warrants regulation as a Class II device but an accessory to the parent device presents lower risks, FDA would regulate the accessory as a Class I rather than a Class II device.
This could be helpful and useful to a lot of manufacturer's..
Read more HERE
 
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Chrisx

Involved In Discussions
#2
Re: FDA proposal on Medical Device Accessories

At least for me the guidance is not helpful at all. We manufacture spinal implants, with a complete line of surgical instruments designed to be used with the implant. For example, this might be a screwdriver. According to this guidance, the screwdriver might be a class I device product code HXX. Alternatively, the FDA might decide on the basis of risk that it is to be regulated as an accessory to the implant. Product code HXX is exempt from design controls, but spinal implants are not. I can never be sure if the instruments are subject to design controls. FDAs suggestion is that I submit a de novo for every instrument we manufacture to determine the device classification. This is a practical way to determine device classification for a simple surgical instrument!:mad:

Furthermore, the guidance doesn't really describe how a class II device accessory is to be regulated. Does the screwdriver need its own 510(k)? Does it require predicate? What if I change the material of the screwdriver, does this require a special 510(K)? Where would I find the predicate for the screwdriver, since code HXX is exempt from premarket notification.

Of course, I have picked an extreme example by selecting the screwdriver. However there are many instruments. Product codes have no definition with them to help understand what device applies. For example, there is a product code HXE for "fork". A rod fork is a fork shaped device used with pedicle screws for distraction. Does a rod fork belong to code HXE? It becomes very hard to know whether a device will be considered an orthopedic manual surgical instrument according to 21CFR888.4540 or an accessory. One can never know for sure when design controls or premarket notification is required. Too bad FDA can't agree to classify accessories on their own, like most other countries.
 

Mark Meer

Trusted Information Resource
#3
Re: FDA proposal on Medical Device Accessories

I agree that what's missing is more guidance as to what are the implications of accessories.

For example, I have a system that consists of a Class II device (parent), and a remote-control ("accessory"), which have gone through 510k.
So, under the system 510k, the remote-control is also considered Class II.

What happens if I apply de novo classification for the remote-control to have it downgraded to Class I with it's own procode? Would this mean that I'm now essentially manufacturing 2 separate devices that should be treated independently?

...that said, I probably need to do a bit more reading... :read:

----

On another note, I imagine the FDA is setting themselves up to receive a flood of de novo requests from this document. ...I hope they've prepared for a backlog! :lol:
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: FDA proposal on Medical Device Accessories

What happens if I apply de novo classification for the remote-control to have it downgraded to Class I with it's own procode? Would this mean that I'm now essentially manufacturing 2 separate devices that should be treated independently?
Yes.

:yes:
 

somashekar

Staff member
Super Moderator
#5
Re: FDA proposal on Medical Device Accessories

The definition of "accessory" requires that the accessory is specifically
intended by the manufacturer of the accessory to be used together with a
device. The intended use of the accessory must be such as to enable a device
to be used in accordance with its intended use. Therefore a product can only
become an accessory to a medical device if the manufacturer of such a
product establishes an intended use in conjunction with one or several
medical devices.

MEDDEV gives the above definition for medical device accessory.
THIS thread adds some more.
Also the Similar Discussion Threads under is valuable.
So an orthopedic tool does not become an accessory.
You may also have a case where the accessory class can be higher to that of the medical device ...
 

Mark Meer

Trusted Information Resource
#6
Re: FDA proposal on Medical Device Accessories

You may also have a case where the accessory class can be higher to that of the medical device ...
...so then what would be the reason a manufacturer of such an accessory to make a de novo application? ...it'd only just make their life more complicated.

As far as I can tell the FDA isn't mandating classifying accessories in this way. ...so the question is why would a manufacturer choose to?

Certainly in this case (and even, to a lesser extent, with downgrading the accessory class) it seems like a whole lot of headache...especially if the device and accessories are all being manufactured together under the same controls anyway...
 
M

MIREGMGR

#7
Re: FDA proposal on Medical Device Accessories

As far as I can tell the FDA isn't mandating classifying accessories in this way. ...so the question is why would a manufacturer choose to?
My employer markets several hundred products that are accessories to devices for which we are not regulatorily responsible. Our products meet the definition of accessory, and do not meet the definition of device. A significant hoop-jumping exercise is required by FDA to regulate them as devices in their own right.

Quite a few of these are low risk accessories for medium risk 510(k)ed products where our products were not included in the 510(k), either because the maker of the 510(k)ed product isn't making any money off our accessory so they didn't see a reason to include it, or our accessory didn't exist yet when the 510(k) was created.

So maybe the new guidance is our fault. :)
 
Last edited by a moderator:

Mark Meer

Trusted Information Resource
#8
Re: FDA proposal on Medical Device Accessories

...products that are accessories to devices for which we are not regulatorily responsible. Our products meet the definition of accessory, and do not meet the definition of device...
MIREGMGR: can you give example(s)?

My confusion stems from the following device definition:
"...instrument, apparatus, ...., or other similar or related article, including any component, part, or accessory"

and accessory definition: "A device that is intended to support, supplement, and/or augment the performance of one or more parent devices"

(underlines added)

So I'm confused as to how something can be a medical device accessory, but not a device...
 
M

MIREGMGR

#9
Re: FDA proposal on Medical Device Accessories

I appreciate the difficulty of dealing with FDA's legacy wording choices.

The full definition of "device", of course, is:

...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
-recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
-intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
-intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.​
Historically, FDA has considered medical products that are "intended to support, supplement, and/or augment the performance of one or more parent devices", but by themselves do not meet one of the three definitional conditions above except in a procedural proximity sense, to be accessories and therefore subject to most device regulation but not devices in their own regard.

Some Product Codes explicitly include relevant accessories. Others do not; whether relevant accessories are covered by them is a complicated question. Some Product Codes describe product types that arguably do not meet the device definition above, except in a broad sense; it appears to me that historically such Product Codes were intended to encompass the accessories to another device type.

As an example, there is a separate product code for a mounting trolley for an overhead suspended, track mounted surgical light. I don't know why in an historical sense, since surgical light mounting historically has been arranged by the light system manufacturer and has been specific to a particular light design, and surgical lights historically have required a 510(k). Therefore one would think that the mounting trolley would be included in the light system's 510(k). To the best of my knowledge, no 510(k)s have ever been issued under this mounting trolley Product Code.

I've discussed this Product Code with FDA, because (for a complex reason) we've considered marketing a mounting trolley for another device maker's surgical light system. 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.
 

Michael Malis

Quite Involved in Discussions
#10
Re: FDA proposal on Medical Device Accessories

MIREGMGR said:
I've discussed this Product Code with FDA, because (for a complex reason) we've considered marketing a mounting trolley for another device maker's surgical light system. 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 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.
 
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