Regulatory Open Forum

Hello everyone,

I found an interesting question probably regarding promotional material and the SaMD, and the answer given by the RAC exam was B.
Can anyone help me explain why it's not promotional material nor a medical device that fulfills MD enforcement discretion, which I suppose is still under FDA's regulation?  Any comments would be appreciated

Q: A drug manufacturer creates a game-based simulation to assist diabetes patients with the management of their blood glucose levels and to motivate them tp adhere to their medication schedules. The game will be based on a password-protected website that will be made available to patients when an FDA-approved drug is prescribed to them. How will the game most likely be regulated by FDA?
A. It should be included as part of the NDA submission
B. It will not be an FDA-regulated product
C. It will be regulated as a class I medical device


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Hsiangling Hsu


United States
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My focus goes to the line "motivate them tp adhere to their medication schedules". FDA does not want to regulate low risk products and those that are for general wellness. Taking medication on the prescribed schedule can be considered common knowledge and a choice that "may reduce the risk or impact of the disease or condition", so the software could possibly be considered 'general wellness', thus not regulated by the FDA. Refer to FDA Guidance Document: General Wellness: Policy for Low Risk Devices, September 2019.

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Brian Johnson
Regulatory & Quality Professional. I help get Medical Devices and SaMD's on the market .
ROCK HILL SC
United States
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Original Message:
Sent: 16-Jan-2023 14:31
From: Hsiangling Hsu
Subject: Promotional material : game-based simulation to assist blood glucose management

Hello everyone,

I found an interesting question probably regarding promotional material and the SaMD, and the answer given by the RAC exam was B.
Can anyone help me explain why it's not promotional material nor a medical device that fulfills MD enforcement discretion, which I suppose is still under FDA's regulation?  Any comments would be appreciated

Q: A drug manufacturer creates a game-based simulation to assist diabetes patients with the management of their blood glucose levels and to motivate them tp adhere to their medication schedules. The game will be based on a password-protected website that will be made available to patients when an FDA-approved drug is prescribed to them. How will the game most likely be regulated by FDA?
A. It should be included as part of the NDA submission
B. It will not be an FDA-regulated product
C. It will be regulated as a class I medical device


------------------------------
Hsiangling Hsu


United States
------------------------------

Hi Brian,

Thank you both for your insights and elaboration. 


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Hsiangling Hsu


United States
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Original Message:
Sent: 19-Jan-2023 10:55
From: Brian Johnson
Subject: Promotional material : game-based simulation to assist blood glucose management

My focus goes to the line "motivate them tp adhere to their medication schedules". FDA does not want to regulate low risk products and those that are for general wellness. Taking medication on the prescribed schedule can be considered common knowledge and a choice that "may reduce the risk or impact of the disease or condition", so the software could possibly be considered 'general wellness', thus not regulated by the FDA. Refer to FDA Guidance Document: General Wellness: Policy for Low Risk Devices, September 2019.

------------------------------
Brian Johnson
Regulatory & Quality Professional. I help get Medical Devices and SaMD's on the market .
ROCK HILL SC
United States

Original Message:
Sent: 16-Jan-2023 14:31
From: Hsiangling Hsu
Subject: Promotional material : game-based simulation to assist blood glucose management

Hello everyone,

I found an interesting question probably regarding promotional material and the SaMD, and the answer given by the RAC exam was B.
Can anyone help me explain why it's not promotional material nor a medical device that fulfills MD enforcement discretion, which I suppose is still under FDA's regulation?  Any comments would be appreciated

Q: A drug manufacturer creates a game-based simulation to assist diabetes patients with the management of their blood glucose levels and to motivate them tp adhere to their medication schedules. The game will be based on a password-protected website that will be made available to patients when an FDA-approved drug is prescribed to them. How will the game most likely be regulated by FDA?
A. It should be included as part of the NDA submission
B. It will not be an FDA-regulated product
C. It will be regulated as a class I medical device


------------------------------
Hsiangling Hsu


United States
------------------------------

Hsiangling,

    If this were a real-world issue, your intuitions are good.   For example, whether or not the game is promotional material is a question that does need to be addressed.

However, I'd encourage you to think less in a real-world way, and more in a narrow "test-taker" way, as your goal is to get to the correct answer on an exam as fast as possible.

If you look at option A, it would not make sense to include a medical device with an NDA unless it were a companion diagnostic, which it is not because the app is a post-prescription element to promote adherence to label.   So you cross off A.

You look at B and are thinking about the correct category, which is enforcement discretion under the relevant guidance documents, as Brian also noted.  If you know the guidance docs in this area, you may see that this does fit, and you pick B.  Note that the question does not ask about promotion, so there is no benefit, during a test, of considering that.   But let's say that, during the test, you can't recall whether this example squarely fits into the enforcement discretion category.

You look at C and hopefully you'll know it can also be eliminated, as the FDA has not created a "Class I" grouping for this area.   They certainly could have, but it would not have addressed the FDA's primary problem, which was insufficient resources to regulate low-risk devices.   The enforcement discretion was applied to devices that were arguably Class II devices, so it would not make sense to say Class I would apply as you would have heard about general wellness apps being Class I devices.    So you eliminate C and are left with B, even if you couldn't fully recall the guidance.

Good luck.


Roger




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Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361
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Original Message:
Sent: 16-Jan-2023 14:31
From: Hsiangling Hsu
Subject: Promotional material : game-based simulation to assist blood glucose management

Hello everyone,

I found an interesting question probably regarding promotional material and the SaMD, and the answer given by the RAC exam was B.
Can anyone help me explain why it's not promotional material nor a medical device that fulfills MD enforcement discretion, which I suppose is still under FDA's regulation?  Any comments would be appreciated

Q: A drug manufacturer creates a game-based simulation to assist diabetes patients with the management of their blood glucose levels and to motivate them tp adhere to their medication schedules. The game will be based on a password-protected website that will be made available to patients when an FDA-approved drug is prescribed to them. How will the game most likely be regulated by FDA?
A. It should be included as part of the NDA submission
B. It will not be an FDA-regulated product
C. It will be regulated as a class I medical device


------------------------------
Hsiangling Hsu


United States
------------------------------