@retiutut Are there any rules, regulations or guidelines issued by the United States of America Food and Drug Administration or OpenBCI itself which affect hiring out the Cyton Board and associated headgear as a non-medical device?
I'm not sure about the wording of your question, but you can look at the OpenBCI Liability Policy which says the intended use for current OpenBCI hardware is as follows:
OpenBCI, Inc. provides the OpenBCI-trademarked products under the following conditions: This evaluation board/kit is intended for use for ENGINEERING DEVELOPMENT, DEMONSTRATION, OR EVALUATION PURPOSES ONLY and is not considered by OpenBCI, Inc. to be a finished end-product fit for general consumer use.
@scipio As you and @retiutut have alluded to, OpenBCI products are not FDA or CE certified, which depending on how your experiment or data-sampling procedure is set-up, could limit the usability of your data/study findings. It may help to refer to the searchable Research Collection, where you can see the OpenBCI hardware-based papers that have been successfully published:
I think as long as you and the subject involved, acknowledge that the application is not 'medical', but instead oriented towards research, investigation, exploration, experimentation; and the subject agrees to participate under those conditions -- that there should then be no expectations on behalf of you or the subject.
I'm not sure why you are using the term "hiring out". It implies you are providing a 'service' to the subject and they would be paying you for it. Seems better to just classify the trial experiments as investigational, since you may not know what benefits if any accrue. Perhaps once you get a handle on the efficacy for the desired goal, that would be more appropriate.
In formal research environments such as universities, hospitals, clinics, that are running clinical trials -- proposed experiments are generally approved by an IRB Institutional Review Board. And this is done for the safety of the subject.
Most IRBs would expect the equipment to be used, to have some sort of medical certification. OpenBCI does not have this, as mentioned in the first link given by Richard. That does not imply that there is a shock hazard risk. Only that medical certification is very expensive, costing typically tens of thousands of dollars. Since OpenBCI equipment is battery powered, there is no pathway that mains current can flow into the subject (in the event of equipment failure.)
The other area to compare this to, would be the field of neurofeedback. Where there are now many consumer devices being used as aids for meditation, relaxation, flow states, etc. Almost none of this consumer equipment has any medical certification.
@wjcroft 'Since OpenBCI equipment is battery powered, there is no pathway that mains current can flow into the subject (in the event of equipment failure.)'
Regarding this comment, I think you once discussed with me the possibility of enclosing the Cyton with a plastic box so that a live wire in its vicinity could not come into contact with its 8 differential, high gain, low noise input channels.
@wjcroft@retiutut Perhaps, you are aware that the NeurOptimal neurofeedback device is sometimes rented/hired out by its owners to those not inclined or able to buy one and, yet, as far as I am aware, the NeurOptimal is not certified by the FDA or the equivalent regulatory body in Canada as a medical device.
@wjcroft A cardboard box would.also afford a little protection against spillages of liquid into the Cyton board, for instance in a hospital environment.
The previous link I gave for enclosures fitting OpenBCI boards, I don't believe any of these are waterproof. If modest water protection is important for you, you can always place the board (+ battery) in a ziploc plastic bag before inserting into small box. (Wire entry sealed with a layer of tape.)
re: NeurOptimal. Yes I'm aware of various neurofeedback training modalities. Most practitioners do charge session fees. And some 'remote' sessions involve equipment rental. Many neurofeedback equipment types do not have official certifications. If you are in Nigeria, I'm not even clear what regulatory body is involved; not FDA or CE.
You might enquire in your setting, how devices such as Muse or Emotiv would be handled. They do not have certification, but have wide usage in consumer and research applications.
It may make sense to drop the phrase "hiring out OpenBCI equipment", and just state that you are offering some type of EEG service and that there is a session fee. That then makes it clear you are offering a specific technical service.
@wjcroft said:
re: NeurOptimal. Yes I'm aware of various neurofeedback training modalities. Most practitioners do charge session fees. And some 'remote' sessions involve equipment rental. Many neurofeedback equipment types do not have official certifications. If you are in Nigeria, I'm not even clear what regulatory body is involved; not FDA or CE.
You might enquire in your setting, how devices such as Muse or Emotiv would be handled. They do not have certification, but have wide usage in consumer and research applications.
Yes, in Nigeria, we have a body which is simply a replica of the United States of America model being called "NAFDAC" (National Agency for Food and Drug Administration). It would appear wise to direct one's enquiry to them before offering any type of EEG Research-oriented services. Government officials here in Nigeria tend to seal up businesses at the slightest pretext.
It would appear wise to direct one's enquiry to them
No, actually I'd say the opposite. These government certification agencies primarily want to regulate manufacturers of equipment. Medical devices to be specific. Just relax. You are not a manufacturer. You are just informally conducting some experimentation and research on a 'hobbyist' / 'Maker' / 'private researcher' basis.
If you do eventually decide to sell devices and services in this area, then yes, it would be appropriate to see what requirements must be fulfilled. Even in that case you generally first work with a local medical device consultancy to guide you in the process. Getting involved directly with an FDA type agency would be asking for trouble. Because their mission is to "shut down" any entity not compliant with their (generally) very very complex and voluminous stacks of regulations.
@wjcroft Thanks for your efforts to resolve this thread. I happen to own a DAVID Alert Pro device which would be easier to rent out without that anxiety of being one day suddenly confronted by officials of an FDA-like agency because it is in the established realm of 'mind machines' which are widely known and recognised to be used for meditative/relaxation states. But, even the DAVID Alert Pro comes with a warning from the manufacturer (Mind Alive) that it is not to be used in the case of those prone to suffer from seizures, unless under the supervision of a mental health professional who, normally, has been trained or certified in the field of some form of psychotherapy. The case of the Cyton and associated headgear is slightly different as one does not need any training, or certification whatsoever to own, import or operate it.
@wjcroft@scipio I don't see the harm of simply "renting" out technology that you own, without any specific promises and relay the terms of use for the tech (example: OpenBCI Liability Doc). You could be renting out time to play with VR headsets, and I would think this is allowed in your country?
In another example, using OpenBCI tech to provide users a non-medical experience or game session should be considered a "service" or "product". This is possible because of the open-source policy and MIT license.
Comments
I'm not sure about the wording of your question, but you can look at the OpenBCI Liability Policy which says the intended use for current OpenBCI hardware is as follows:
https://docs.openbci.com/docs/08FAQ/Liability
@scipio As you and @retiutut have alluded to, OpenBCI products are not FDA or CE certified, which depending on how your experiment or data-sampling procedure is set-up, could limit the usability of your data/study findings. It may help to refer to the searchable Research Collection, where you can see the OpenBCI hardware-based papers that have been successfully published:
https://docs.openbci.com/citations
Hope this helps. Perhaps @wjcroft has thoughts on this?
I think as long as you and the subject involved, acknowledge that the application is not 'medical', but instead oriented towards research, investigation, exploration, experimentation; and the subject agrees to participate under those conditions -- that there should then be no expectations on behalf of you or the subject.
I'm not sure why you are using the term "hiring out". It implies you are providing a 'service' to the subject and they would be paying you for it. Seems better to just classify the trial experiments as investigational, since you may not know what benefits if any accrue. Perhaps once you get a handle on the efficacy for the desired goal, that would be more appropriate.
In formal research environments such as universities, hospitals, clinics, that are running clinical trials -- proposed experiments are generally approved by an IRB Institutional Review Board. And this is done for the safety of the subject.
https://www.google.com/search?q=institutional+review+board
Most IRBs would expect the equipment to be used, to have some sort of medical certification. OpenBCI does not have this, as mentioned in the first link given by Richard. That does not imply that there is a shock hazard risk. Only that medical certification is very expensive, costing typically tens of thousands of dollars. Since OpenBCI equipment is battery powered, there is no pathway that mains current can flow into the subject (in the event of equipment failure.)
William
The other area to compare this to, would be the field of neurofeedback. Where there are now many consumer devices being used as aids for meditation, relaxation, flow states, etc. Almost none of this consumer equipment has any medical certification.
@wjcroft 'Since OpenBCI equipment is battery powered, there is no pathway that mains current can flow into the subject (in the event of equipment failure.)'
Regarding this comment, I think you once discussed with me the possibility of enclosing the Cyton with a plastic box so that a live wire in its vicinity could not come into contact with its 8 differential, high gain, low noise input channels.
https://www.google.com/search?as_q=enclosure&as_sitesearch=openbci.com
In general there are no "live wires" exposed in homes / offices. But an easy option is a simple cardboard box.
https://openbci.com/forum/index.php?p=/discussion/2392/safety-housing-for-cyton-resolved
@wjcroft @retiutut Perhaps, you are aware that the NeurOptimal neurofeedback device is sometimes rented/hired out by its owners to those not inclined or able to buy one and, yet, as far as I am aware, the NeurOptimal is not certified by the FDA or the equivalent regulatory body in Canada as a medical device.
@wjcroft A cardboard box would.also afford a little protection against spillages of liquid into the Cyton board, for instance in a hospital environment.
The previous link I gave for enclosures fitting OpenBCI boards, I don't believe any of these are waterproof. If modest water protection is important for you, you can always place the board (+ battery) in a ziploc plastic bag before inserting into small box. (Wire entry sealed with a layer of tape.)
re: NeurOptimal. Yes I'm aware of various neurofeedback training modalities. Most practitioners do charge session fees. And some 'remote' sessions involve equipment rental. Many neurofeedback equipment types do not have official certifications. If you are in Nigeria, I'm not even clear what regulatory body is involved; not FDA or CE.
https://en.wikipedia.org/wiki/CE_marking
You might enquire in your setting, how devices such as Muse or Emotiv would be handled. They do not have certification, but have wide usage in consumer and research applications.
It may make sense to drop the phrase "hiring out OpenBCI equipment", and just state that you are offering some type of EEG service and that there is a session fee. That then makes it clear you are offering a specific technical service.
@wjcroft
Yes, in Nigeria, we have a body which is simply a replica of the United States of America model being called "NAFDAC" (National Agency for Food and Drug Administration). It would appear wise to direct one's enquiry to them before offering any type of EEG Research-oriented services. Government officials here in Nigeria tend to seal up businesses at the slightest pretext.
No, actually I'd say the opposite. These government certification agencies primarily want to regulate manufacturers of equipment. Medical devices to be specific. Just relax. You are not a manufacturer. You are just informally conducting some experimentation and research on a 'hobbyist' / 'Maker' / 'private researcher' basis.
If you do eventually decide to sell devices and services in this area, then yes, it would be appropriate to see what requirements must be fulfilled. Even in that case you generally first work with a local medical device consultancy to guide you in the process. Getting involved directly with an FDA type agency would be asking for trouble. Because their mission is to "shut down" any entity not compliant with their (generally) very very complex and voluminous stacks of regulations.
https://www.google.com/search?q=medical+device+certification+consulting
@wjcroft Thanks for your efforts to resolve this thread. I happen to own a DAVID Alert Pro device which would be easier to rent out without that anxiety of being one day suddenly confronted by officials of an FDA-like agency because it is in the established realm of 'mind machines' which are widely known and recognised to be used for meditative/relaxation states. But, even the DAVID Alert Pro comes with a warning from the manufacturer (Mind Alive) that it is not to be used in the case of those prone to suffer from seizures, unless under the supervision of a mental health professional who, normally, has been trained or certified in the field of some form of psychotherapy. The case of the Cyton and associated headgear is slightly different as one does not need any training, or certification whatsoever to own, import or operate it.
@wjcroft @scipio I don't see the harm of simply "renting" out technology that you own, without any specific promises and relay the terms of use for the tech (example: OpenBCI Liability Doc). You could be renting out time to play with VR headsets, and I would think this is allowed in your country?
In another example, using OpenBCI tech to provide users a non-medical experience or game session should be considered a "service" or "product". This is possible because of the open-source policy and MIT license.