Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

The company I work for make cloud-based SaMD. Following market authorisation, we want to have KoLs use the product for a period of time during a trial / demo period (in the US). During this period they won't be paying for the product. Are there any regulations around this from an advertising and promotional perspective? Is there anything I should watch out for? Thanks in advance for  insight as this is not an area I am very familiar with.

Hi Anon

A few basic things to think about...

If you have authorisation in the US, mind that your customers/users/patients are in the US, and your advertising is addressed to the US. Cloud-based tools can easily cross borders, and you may not have suitable authorisation everywhere.

If your subscription is free at first and then full price, make that clear in the contracts, so your customers won't be unpleasantly surprised.

If you're planning to share the good things the KOLs say about the product, you're responsible for the presentation and content of the messages. (A disclaimer that their words are their own doesn't allow you to promote statements that are untrue, misleading, or otherwise something you wouldn't be allowed to say.)

If the KOLs will be giving talks or publishing articles about the device, they will need to disclose their association with your company, or the value of the value of the free subscriptions you have awarded them.


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Anne LeBlanc
United States
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Original Message:
Sent: 19-Jan-2023 23:00
From: Anonymous Member
Subject: Free / Demo Product (SaMD)

This message was posted by a user wishing to remain anonymous

The company I work for make cloud-based SaMD. Following market authorisation, we want to have KoLs use the product for a period of time during a trial / demo period (in the US). During this period they won't be paying for the product. Are there any regulations around this from an advertising and promotional perspective? Is there anything I should watch out for? Thanks in advance for  insight as this is not an area I am very familiar with.

This message was posted by a user wishing to remain anonymous

You need to ask this question of a lawyer. Some of the bigger issues are on the legal and compliance side, e.g., FTC, not typical FDA regulatory topics. Giving free or demo product to HCPs has implications outside our scope.
Original Message:
Sent: 19-Jan-2023 23:00
From: Anonymous Member
Subject: Free / Demo Product (SaMD)

This message was posted by a user wishing to remain anonymous

The company I work for make cloud-based SaMD. Following market authorisation, we want to have KoLs use the product for a period of time during a trial / demo period (in the US). During this period they won't be paying for the product. Are there any regulations around this from an advertising and promotional perspective? Is there anything I should watch out for? Thanks in advance for  insight as this is not an area I am very familiar with.

Hi Anon, I believe Anne covered most of the things to look out for. I would add that these types KoL relationships are quite common in the device industry as long as the device is legally marketed and used within its indications. KoLs are important in communicating new devices to the medical community.

Having a contract is a must to delineate the items Anne covered but also to define the purpose of the free trial and what input the company expects from the KoLs. Any feedback (negative/positive or suggestions) must be addressed. Make sure positive feedback aligns with your cleared or authorized claims; negative feedback for complaint/risk analysis and suggestions to improve the device should be reviewed as well in your on-going risk assessment process.

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John DeLucia
Consultant
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Original Message:
Sent: 19-Jan-2023 23:00
From: Anonymous Member
Subject: Free / Demo Product (SaMD)

This message was posted by a user wishing to remain anonymous

The company I work for make cloud-based SaMD. Following market authorisation, we want to have KoLs use the product for a period of time during a trial / demo period (in the US). During this period they won't be paying for the product. Are there any regulations around this from an advertising and promotional perspective? Is there anything I should watch out for? Thanks in advance for  insight as this is not an area I am very familiar with.

Hi Anon,
I think you should have 2 aspects to monitor:
- The state legal aspects which will change from one US state to another US state (For example, a demo period can not be more than 3 months in Texas)
- The Sunshine Act: which will request to clearly define your relationship with the KOL in a contract and will limit the usage .

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Stephane Berger
La Ciotat
France
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Original Message:
Sent: 19-Jan-2023 23:00
From: Anonymous Member
Subject: Free / Demo Product (SaMD)

This message was posted by a user wishing to remain anonymous

The company I work for make cloud-based SaMD. Following market authorisation, we want to have KoLs use the product for a period of time during a trial / demo period (in the US). During this period they won't be paying for the product. Are there any regulations around this from an advertising and promotional perspective? Is there anything I should watch out for? Thanks in advance for  insight as this is not an area I am very familiar with.