Definition Human Use (FDA)

#1
Hi there,

In the FDA no definition is given for "human use". We are considering "human use" simply as (a product) intended to be used within/ or on the human body

It would be very helpful if someone here could confirm this definition. This would mean that a lot of FDA articles are not applicable for our product (accessory of a medical device).

Please let me know, thank you!
 
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Watchcat

Trusted Information Resource
#2
I think FDA would say human use is use in "the diagnosis, cure, mitigation, treatment, or prevention of disease" in humans, whether or not it comes in contact with the body.

I think FDA doesn't define the term "human use" because FDA uses is solely to distinguish human use from animal (veterinary) use, not to describe the nature of the use itself. So whether it is used in, on, around, or near the human body, or remotely, doesn't matter. It is still human use.
 
#3
Thank you very much! Your definition of human use sounds very plausible.

However, I still think that our product is not intended for human use (as it is often mentioned in the FDA). Since our product (a cassette with fixation) is not intended to be used in "the diagnosis, cure, mitigation, treatment or prevention of disease" in humans. It only facilitates the reprocessing of surgical instruments and/or implants in the cassette and promotes a clear overview of the surgical instruments and/or implants in the cassette .
Even though you mentioned that it doesn't matter whether the product is used in, on, around or near the body, the cassette is in its whole not intended to come into (direct) contact with the human body. There is also no "indirect contact" as mentioned in ISO 10993-1:2018, as it refers to medical devices or parts of medical devices through which a liquid or gas passes that physically comes into contact with body tissue.

Do you agree on my statement?
 

Watchcat

Trusted Information Resource
#4
I still think that our product is not intended for human use
I cannot agree or disagree with your statement, because I'm not in a position to agree or disagree. For that you'd have to provide me with all the information on your device and its intended use, and then pay for my time to review the information and probably also to research the issue.

If your interest is limited to ISO 10993, I wouldn't give any thought to whether it is intended for human use, only the nature of the contact, or the lack of contact.

If your interest is broader, then you may be asking the wrong question. Is it a medical device?

How to Determine if Your Product is a Medical Device

If it is a medical device, then it is either for human use or veterinary use. As far as I know, there are no FDA-regulated medical devices that are not intended for either one, even if FDA's idea of "human use" is different from your own. On the other hand, if it is not a medical device (or other FDA regulated product), then whether or not it is for human use is irrelevant..
 

monoj mon

Involved In Discussions
#5
If your interest is broader, then you may be asking the wrong question. Is it a medical device?
Yes, probably this should be the first question to be asked.
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It only facilitates the reprocessing of surgical instruments and/or implants in the cassette and promotes a clear overview of the surgical instruments and/or implants in the cassette .
Looking at this, I feel your product is not even a "device". So as Watchcat has said
On the other hand, if it is not a medical device (or other FDA regulated product), then whether or not it is for human use is irrelevant.
 
#6
Well, I was already questionning whether our product is a medical device (accessory) conform the FDA.

Conform the European Medical Device Directive (MDD) and the Medical Device Regulation (MDR) our product is a medical device (more specific an accessory of a medical device).

Article 2 paragraph 2 MDR: ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).
Our product is intended to be used together with several medical devices (reusable surgical instruments and/or implants) to specifically enable the medical device(s) to be used in accordance with its/their intended purposes (reuse/ reprocessing). As mentioned, part of the intended use of these reusable surgical instruments and/or implants is the reuse/reprocessing, which our product is facilitating. Perhaps I have not described it clearly enough here, but we do meet this requirement.

Now, one of our customers is planning to distribute our product in the U.S. According this customer, our product is a medical device (accessory). Therefore, we started to review the U.S. regulations. While doing this, we were confused. We do not consider our product as an accessory (device) conform Section 201(h) of the FD&C Act.
Recently, this customer told us they have determined our product as a FDA device by U.S. regulation 878.4800 (Manual surgical instrument for general use). This section 878.4800 sub (a) identifies a manual surgical instrument for general use intended to be used in various general surgical procedures as a“Manual surgical instrument for general use”.

However, we do not consider our product as a surgical instrument. Our product is intended to facilitate the reprocessing of the surgical instruments in our product, to protect the surgical instruments in our product against damage that can occur during reprocessing, transport and storage within the health institution and to promote a clear overview of the surgical instruments in our product. The product is not intended for human use and does not deliver any performances during surgical procedures.
The Medical Device Regulation (EU) 2017/745 (MDR) has defined “(reusable) surgical instruments” as: instruments intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilization have been carried out.” (Annex VIII, Chapter 1, 2.3), which clarifies that our product is not a surgical instrument (it is not intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures).

We already asked this customer for explanation, while waiting, I was hoping the definition of "human use" would give me more insight. However, we come across the same question: whether our product is a device/ accessory conform the FDA? I patiently await our customer's answer (they have more recources). Perhaps the FDA uses another definition for (reusable) "surgical instruments" than the MDR?
 

Watchcat

Trusted Information Resource
#7
I don't recommend trying to mix and match the requirements of two different jurisdictions.

The FDA regulatory framework (and mindset) is very different from the EC/MDR. To FDA, if it is used in surgery, it is a surgical device. This includes a lamp, when used in an operating room. If the operation is on a human, that is human use. If it is on some other type of animal, then that is animal use. Take the lamp out of the operating room, and it is no longer a medical device, because it is no longer being used in surgery.
 
#8
I don't recommend trying to mix and match the requirements of two different jurisdictions.

The FDA regulatory framework (and mindset) is very different from the EC/MDR. To FDA, if it is used in surgery, it is a surgical device. This includes a lamp, when used in an operating room. If the operation is on a human, that is human use. If it is on some other type of animal, then that is animal use. Take the lamp out of the operating room, and it is no longer a medical device, because it is no longer being used in surgery.
Thank you very much for your clarification!
 
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