Ana -
You have identified the problem precisely. However, if you look at the definition of a medical device, the screening questionnaire does not meet that definition UNLESS it is used for diagnosis. In your glucose monitoring example, the device analyzes information, which puts it squarely in the medical device category. For the questionnaire I am asking about, the results of the test might lead you to
seek out medical advice, but it does not diagnose anything. This is the problem I've been struggling with, which is why I asked for the input. Everyone's advice has been extrememly helpful. This is not an easy question to answer, and depending on the instrument, the answer could be quite different. In my case, where I landed was that the questionnaire does not provide any diagnosis, treatment, prevention or mitigation of disease and is therefore not a medical device.
Thank you so much for your input!
Best,
Carrie
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Carrie Kuehn RAC
Managing Scientist
Exponent, Inc.
Bellevue WA
United States
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Original Message:
Sent: 08-02-2013 16:31
From: Ana Moura
Subject: Screening Tools as Medical Devices?
Michael,
I have a question about the general example you gave of a Screening Tool that would not be a Medical Device - a tool for patients to record information, and then bring this info to discuss with their doctors.
What criteria are you using for your conclusion? Are you aware that a measuring function alone does not prevent something from being a Med Device?
Whether the ScreenTool is being used at home (Point-of-Care) or at the Clinic, the fact that it measures something related to disease monitoring (biomarkers levels or patient symptom severity) renders it a Med Device. Consider the example of the latest iPhone Diabetes Mobile App from Glooko, a diabetes Data management System that was cleared in DEC 2012 (K122142).
This Med Device software is intended to "assist health care professional and people with diabetes review and analyze blood glucose test results". Not only is this device targeted for both patients at home and for clinicians, but also it consist only of a Measuring Function (review and analyze glucose levels). Actually its Indications For Use specify that "The device is not intended to provide any diagnosis on patient results."
If Carrie's ScreenTool consisted of a Questionnaire (e.g. questions about level of difficulty in doing certain tasks) for patients to answer bi-weekly to track their stroke symptoms, this is by definition a Measuring Function, albeit a subjective one of Patient Outcome Measures. The fact that it's not used to give a diagnosis would not prevent it from being a Med Device.
Another example is the measurement of HbA1C as a tool to monitor long-term glucose control in diabetes patients. For many years firms like Roche and Bio-Rad have sold Class II IVD devices for this Measuring Function. Only recently in May of this year, has Roche been able to clear their TINA-QUANT HBA1C device (K121291) with an indication of "Aid in Diagnosis of Diabetes". I think they achieved this under the condition that they verify their device standardization annually by a certifying Hemoglobin Standardization Org acceptable to FDA.
So, why couldn't Carrie's Screen Tool be a Med Device?
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Ana Moura, MS, RAC
Sr. Specialist, Regulatory Affairs
Celera, Alameda, CA, United States
Original Message:
Sent: 07-26-2013 13:29
From: Michael Swit
Subject: Screening Tools as Medical Devices?
The question you raised is too broad to answer with precision. A screening tool such as you described easily could become a medical device if, for example, the data was entered into a smartphone and sent to a server that then analyzed the data and made a treatment recommendation. If, however, the tool was just used by the patient to record information and then the patient called his/her doctor with the recorded data, in my view, that would not be a medical device.
FDA has given us a draft view on some of these issues in the July 2011 draft guidance on mobile medical applications.
______________________________________________
Michael A. Swit, Esq.
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Duane Morris LLP
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Original Message:
Sent: 07-25-2013 12:08
From: Aimée Campbell
Subject: Screening Tools as Medical Devices?
The screening tools, as you've described them, do not meet the regulatory definition of a medical device; they do not diagnose and they do not affect the body in any way. They seem to be more Marketing-associated and are could potentially be labeling if they mention your approved product.
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Aimée Campbell
Abbott Vascular
Menlo Park CA
United States
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Original Message:
Sent: 07-24-2013 00:55
From: Carrie Kuehn
Subject: Screening Tools as Medical Devices?
Hi folks! I have a question about the status of screening tools in terms of FDA. I am wondering if anyone has had any experience with FDA and their policies on things like questionnaires, patient reported outcome measures, or other similar non-diagnostic screening tools. A tool like this might lead to someone seek out medical care, or might lead a practitioner to conduct more specific diagnostic tests. Or the tool might help someone know their status day-to-day such as a stroke patient who keeps tabs on how fast they are reading or writing. I'd appreciate your sharing any experience you might have in this space, and what your thoughts are on these tools being considered/or not as medical devices. If you have an reference materials you could point me to, I would appreciate that also.
Thanks in advance,
Carrie
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Carrie Kuehn RAC
Managing Scientist
Exponent, Inc.
Bellevue WA
United States
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