Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

If a manufacturer is performing pre-market tests on a medical device, and the testing will involve real clinicians as users but not real patients (dummies will be used), does this mean no human subjects are involved? Is it right to assume then that IDE, IRB, and Informed Consent are all n/a?
The clinician in this case does not seem to fall within either of the following CFR definitions. Thank you for any input anyone can provide on this topic.

21 CFR 812.3(p) 
Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.

45 CFR 46.102(f)
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

From my perspective as long as the device is not being used on/in a human and/or the device does not perform any diagnostic function, monitoring, or providing feedback to the physician or patient, then a clinical trial may not be necessary.  To give you an example, I have been involved in numerous usability studies over the years where we did not obtain IRB approval because a "real" device was not being used.  A simulated or non-functioning device was used, but it did not perform any treatment or diagnosis.  Devices such as pen injectors or CPAP machines have been used that were non-functioning, but allowed us to see if the user, physician, or operator could take it out of the package, put it together, and use properly.  The pen injector fully functioned except there was no needle and no drug injected.  However, anytime a fully functioning device is used on human then IRB and clinical trial must be considered.  And not to say in some companies I worked for we did human tests internal to the company without getting IRB either - maybe not completely correct, but I know a few companies that do something like that as well (more in the feasibility stage and of course depending on the device - not implants and such).

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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 28-May-2018 20:02
From: Anonymous Member
Subject: Is the clinician/user a human subject?

This message was posted by a user wishing to remain anonymous

If a manufacturer is performing pre-market tests on a medical device, and the testing will involve real clinicians as users but not real patients (dummies will be used), does this mean no human subjects are involved? Is it right to assume then that IDE, IRB, and Informed Consent are all n/a?
The clinician in this case does not seem to fall within either of the following CFR definitions. Thank you for any input anyone can provide on this topic.

21 CFR 812.3(p) 
Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.

45 CFR 46.102(f)
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

​Hi folks.

Let me expand a little on what Richard has already noted.  I look at the regulation requiring informed consent, IDE and IRB approvals as a protection for human subjects.  So the question really becomes "Is there any risk of adverse event(s) occurring in this situation that could impact on the health or safety of the human volunteer?"  So if the product was say a radiological instrument that might be using dummies to show that the equipment could properly perform the task and that the user could properly set the instrument up and use the instrument to complete the task by actually doing some "non-functional" or "non-diagnostic" radiography on dummies but that would potentially expose the user to radiation, then an IRB, IDE and informed consent from the user are all things that need to be considered.  If, as Richard provided examples, there is no risk of harm or injury to the humans involved in the study (so in this example no radiation emitted from the device but everything else looks and feels the same as a fully functional system) then I would say you are on pretty solid ground without going through IRB and informed consent.

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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 31-May-2018 07:51
From: Richard Vincins
Subject: Is the clinician/user a human subject?

From my perspective as long as the device is not being used on/in a human and/or the device does not perform any diagnostic function, monitoring, or providing feedback to the physician or patient, then a clinical trial may not be necessary.  To give you an example, I have been involved in numerous usability studies over the years where we did not obtain IRB approval because a "real" device was not being used.  A simulated or non-functioning device was used, but it did not perform any treatment or diagnosis.  Devices such as pen injectors or CPAP machines have been used that were non-functioning, but allowed us to see if the user, physician, or operator could take it out of the package, put it together, and use properly.  The pen injector fully functioned except there was no needle and no drug injected.  However, anytime a fully functioning device is used on human then IRB and clinical trial must be considered.  And not to say in some companies I worked for we did human tests internal to the company without getting IRB either - maybe not completely correct, but I know a few companies that do something like that as well (more in the feasibility stage and of course depending on the device - not implants and such).

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 28-May-2018 20:02
From: Anonymous Member
Subject: Is the clinician/user a human subject?

This message was posted by a user wishing to remain anonymous

If a manufacturer is performing pre-market tests on a medical device, and the testing will involve real clinicians as users but not real patients (dummies will be used), does this mean no human subjects are involved? Is it right to assume then that IDE, IRB, and Informed Consent are all n/a?
The clinician in this case does not seem to fall within either of the following CFR definitions. Thank you for any input anyone can provide on this topic.

21 CFR 812.3(p) 
Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.

45 CFR 46.102(f)
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.