Biocompatibility Test for a Non Contact Medical Device

[Cybel]

Hi there,

we have a 510(k) under review, it is for a non contact infrared thermometer.
The device does not come in contact with the patient, and it is handled by the operator (the part in contact with the hand of the operator is made of raw material which is biocompatible with up to 30 days human contact duration according to USP Class VI and ISO 10993-1).
The contact time of our device, in normal use, is of 5 seconds maximum per measurement. The device is intended for home healthcare, so it is supposed to be use occasionally and in order to take a very limited number of readings.

The FDA reviewer is asking for biocompatibility tests, "since the device does come into contact with the caregiver".
Being a surface device, with contact duration A and intact skin contact, only the basic tests are required, but I think that the reviewer should at least evaluate our risk assessment in order to determine if testing is needed, before ask for tests, as the device can be considered with "transient contact".

Do you have any suggestion?

Thank you very much in advance!
Cybel

 

[Ronen E]

Hi there,

we have a 510(k) under review, it is for a non contact infrared thermometer.
The device does not come in contact with the patient, and it is handled by the operator (the part in contact with the hand of the operator is made of raw material which is biocompatible with up to 30 days human contact duration according to USP Class VI and ISO 10993-1).
The contact time of our device, in normal use, is of 5 seconds maximum per measurement. The device is intended for home healthcare, so it is supposed to be use occasionally and in order to take a very limited number of readings.

The FDA reviewer is asking for biocompatibility tests, "since the device does come into contact with the caregiver".
Being a surface device, with contact duration A and intact skin contact, only the basic tests are required, but I think that the reviewer should at least evaluate our risk assessment in order to determine if testing is needed, before ask for tests, as the device can be considered with "transient contact".

Do you have any suggestion?

Thank you very much in advance!
Cybel

Hi Cybel,

Are you aware of this guidance document? It offers some leverage points in your situation, and is supposed to represent the FDA's current thinking on the topic.

Would be interesting to find out how well your FDA examiner knows this document...

Cheers,
Ronen.

 

[Cybel]

Hi Ronen,
thank you for your comment. Yes, I'm aware of the guidance.
I think that also the reviewer is, because this guidance is the only document (from what I know) where biocompatibility is considered also with respect of the operator.
I think also that the guidance is oriented in avoiding biocompatibility tests were not necessary, and that my device falls into that case.

But the reviewer seems to be inflexible.

:-(

 

[Ronen E]

Hi Ronen,
thank you for your comment. Yes, I'm aware of the guidance.
I think that also the reviewer is, because this guidance is the only document (from what I know) where biocompatibility is considered also with respect of the operator.
I think also that the guidance is oriented in avoiding biocompatibility tests were not necessary, and that my device falls into that case.

But the reviewer seems to be inflexible.

:-(

I think that the guidance speaks quite clearly in your favour. You could appeal to that reviewer's superiors, and if that doesn't help you have this option. There should be transparency and accountability in the system.

 

[Julie O]

I think that the reviewer should at least evaluate our risk assessment in order to determine if testing is needed, before ask for tests

This may be a left-hand/right-hand issue at FDA. I think biocompatibility is often a specialized review conducted by a biocompatibility expert, where the risk assessment is reviewed by someone else, probably the lead reviewer.

When you say "the FDA reviewer ," do mean a specific person you have spoken to or have received an email from, or are you referring to an official written communication from the Agency?

You imply, but do not state, that the FDA reviewer you refer to hasn't evaluated your risk assessment. Do you know if that is the case?

Is this a 510(k) or De novo review?

 

[Cybel]

I think that the guidance speaks quite clearly in your favour. You could appeal to that reviewer's superiors, and if that doesn't help you have [ ]. There should be transparency and accountability in the system.

Thank you.
I will consider this possibility.

 

[Cybel]

This may be a left-hand/right-hand issue at FDA. I think biocompatibility is often a specialized review conducted by a biocompatibility expert, where the risk assessment is reviewed by someone else, probably the lead reviewer.

When you say "the FDA reviewer ," do mean a specific person you have spoken to or have received an email from, or are you referring to an official written communication from the Agency?

You imply, but do not state, that the FDA reviewer you refer to hasn't evaluated your risk assessment. Do you know if that is the case?

Is this a 510(k) or De novo review?

Hi Julie, I mean the person who sent us the deficiency letter. The application is a 510(k). I've not submitted a specific risk assessment about biocompatibility, I've only justified in my general Risk Analysis report why biocompatibility tests are not necessary. I guess it is not enough, and obviously I'm completely available in preparing a more detailed document, but he doesn't want it...

 

[Ronen E]

Hi Julie, I mean the person who sent us the deficiency letter. The application is a 510(k). I've not submitted a specific risk assessment about biocompatibility, I've only justified in my general Risk Analysis report why biocompatibility tests are not necessary. I guess it is not enough, and obviously I'm completely available in preparing a more detailed document, but he doesn't want it...

That risk analysis should have been an integral part of the biocompatibility section of your 510(k). One needs to lead the reviewer down the preferred path and not count on them connecting the dots. I hope it's not too late. In theory it shouldn't be, but practice doesn't always align with theory.

 

[Cybel]

That risk analysis should have been an integral part of the biocompatibility section of your 510(k). One needs to lead the reviewer down the preferred path and not count on them connecting the dots. I hope it's not too late. In theory it shouldn't be, but practice doesn't always align with theory.

I will learn from this.
You are perfectly right...
Thank you!

 

[Kaosk8e]

In Reference to the FDA guidance document posted earlier in the thread - I think the footnote on page 1 just beneath the Introduction may be what the FDA reviewer is using to push back; the key words being their definition of "human body".

"For the purposes of this document, the term “human body” refers to either patient tissues or the clinical practitioner. For example, masks or gloves intended for protective purposes by clinical practitioners should be assessed for biocompatibility. Similarly, medical devices such as implants or skin electrodes also should be assessed for biocompatibility."