Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I have an ad/promo question. The regulations for US Class II devices are clear in that you cannot misbrand and represent indications for use that have not been cleared. However, for Class I devices, I am having a hard time finding information. We are creating promo materials for a clinical chemistry device that contains intended use. The marketing team has consulted with physicians who have written letters of support specifying which conditions the device helps with diagnosing. I have the following questions:

1. Are there any guidance documents for how to use/market physician letters of support for Class I devices?
2. Can specific diseases/conditions be stated in marketing materials for Class I devices?
3. Can specific diseases/conditions be stated in marketing materials for Class I devices if they reference the physician letter mentioned in #1?

As a regulatory professional, my thought is that anything that goes beyond intended use ("the device measures x") and goes into the territory of indications for use ("the device can be useful for physicians diagnosing x, y, or z") should not be stated. As I understand it, for Class I devices, promo material can only state what the instrument does as there are no indications for use that can be cleared. I would appreciate any guidance on this.

Thank you for your time.​

It is most important to remember that tThe laws covering misbranding, off label use and promotion are independent of risk or classification. 

With regards to off label use and promotion, these are a combination of FDA and FTC requirements.

------------------------------
Lee Leichter RAC
President
Fort Myers FL
United States
------------------------------

Original Message:
Sent: 07-Dec-2018 10:16
From: Anonymous Member
Subject: Ad/promo question

This message was posted by a user wishing to remain anonymous

Hello,

I have an ad/promo question. The regulations for US Class II devices are clear in that you cannot misbrand and represent indications for use that have not been cleared. However, for Class I devices, I am having a hard time finding information. We are creating promo materials for a clinical chemistry device that contains intended use. The marketing team has consulted with physicians who have written letters of support specifying which conditions the device helps with diagnosing. I have the following questions:

1. Are there any guidance documents for how to use/market physician letters of support for Class I devices?
2. Can specific diseases/conditions be stated in marketing materials for Class I devices?
3. Can specific diseases/conditions be stated in marketing materials for Class I devices if they reference the physician letter mentioned in #1?

As a regulatory professional, my thought is that anything that goes beyond intended use ("the device measures x") and goes into the territory of indications for use ("the device can be useful for physicians diagnosing x, y, or z") should not be stated. As I understand it, for Class I devices, promo material can only state what the instrument does as there are no indications for use that can be cleared. I would appreciate any guidance on this.

Thank you for your time.​

Correct, it does not matter whether Class II, Class I, or Class III in the United States, promotion, mis-branding, unwarranted claims, false claims, etc. all fall under the same statute that governs all medical devices.  So marketing materials or physician support letters for Class I devices should be treated like any other medical device.  If there are claims being made for diagnostic purposes that exceed the regulation, then you may need to either remove until those claims are substantiated or you have a legally cleared device for those indications.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Pembroke Pines FL
United States
------------------------------

Original Message:
Sent: 08-Dec-2018 08:10
From: Lee Leichter
Subject: Ad/promo question

It is most important to remember that tThe laws covering misbranding, off label use and promotion are independent of risk or classification.

With regards to off label use and promotion, these are a combination of FDA and FTC requirements.

------------------------------
Lee Leichter RAC
President
Fort Myers FL
United States

Original Message:
Sent: 07-Dec-2018 10:16
From: Anonymous Member
Subject: Ad/promo question

This message was posted by a user wishing to remain anonymous

Hello,

I have an ad/promo question. The regulations for US Class II devices are clear in that you cannot misbrand and represent indications for use that have not been cleared. However, for Class I devices, I am having a hard time finding information. We are creating promo materials for a clinical chemistry device that contains intended use. The marketing team has consulted with physicians who have written letters of support specifying which conditions the device helps with diagnosing. I have the following questions:

1. Are there any guidance documents for how to use/market physician letters of support for Class I devices?
2. Can specific diseases/conditions be stated in marketing materials for Class I devices?
3. Can specific diseases/conditions be stated in marketing materials for Class I devices if they reference the physician letter mentioned in #1?

As a regulatory professional, my thought is that anything that goes beyond intended use ("the device measures x") and goes into the territory of indications for use ("the device can be useful for physicians diagnosing x, y, or z") should not be stated. As I understand it, for Class I devices, promo material can only state what the instrument does as there are no indications for use that can be cleared. I would appreciate any guidance on this.

Thank you for your time.​

This message was posted by a user wishing to remain anonymous

OP here.

Thank you both for the insight, it is much appreciated. Seems like I will need to communicate to the marketing department that the physical letter of support obtained cannot be used as-is for marketing because it contains specific indications for use and will need to be modified. (These letters were obtained without reg dept knowledge).

Follow up question:
Can a Class I device be cleared through the 510k process if a company would like to add diagnostic claims to its intended use? Obviously it is unlikely that the company would pursue this path, but I want to know if this is possible in theory.

Thanks again.
Original Message:
Sent: 09-Dec-2018 04:04
From: Richard Vincins
Subject: Ad/promo question

Correct, it does not matter whether Class II, Class I, or Class III in the United States, promotion, mis-branding, unwarranted claims, false claims, etc. all fall under the same statute that governs all medical devices.  So marketing materials or physician support letters for Class I devices should be treated like any other medical device.  If there are claims being made for diagnostic purposes that exceed the regulation, then you may need to either remove until those claims are substantiated or you have a legally cleared device for those indications.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Pembroke Pines FL
United States

Original Message:
Sent: 08-Dec-2018 08:10
From: Lee Leichter
Subject: Ad/promo question

It is most important to remember that tThe laws covering misbranding, off label use and promotion are independent of risk or classification.

With regards to off label use and promotion, these are a combination of FDA and FTC requirements.

------------------------------
Lee Leichter RAC
President
Fort Myers FL
United States

Original Message:
Sent: 07-Dec-2018 10:16
From: Anonymous Member
Subject: Ad/promo question

This message was posted by a user wishing to remain anonymous

Hello,

I have an ad/promo question. The regulations for US Class II devices are clear in that you cannot misbrand and represent indications for use that have not been cleared. However, for Class I devices, I am having a hard time finding information. We are creating promo materials for a clinical chemistry device that contains intended use. The marketing team has consulted with physicians who have written letters of support specifying which conditions the device helps with diagnosing. I have the following questions:

1. Are there any guidance documents for how to use/market physician letters of support for Class I devices?
2. Can specific diseases/conditions be stated in marketing materials for Class I devices?
3. Can specific diseases/conditions be stated in marketing materials for Class I devices if they reference the physician letter mentioned in #1?

As a regulatory professional, my thought is that anything that goes beyond intended use ("the device measures x") and goes into the territory of indications for use ("the device can be useful for physicians diagnosing x, y, or z") should not be stated. As I understand it, for Class I devices, promo material can only state what the instrument does as there are no indications for use that can be cleared. I would appreciate any guidance on this.

Thank you for your time.​

Original Message------

This message was posted by a user wishing to remain anonymous

OP here.

Thank you both for the insight, it is much appreciated. Seems like I will need to communicate to the marketing department that the physical letter of support obtained cannot be used as-is for marketing because it contains specific indications for use and will need to be modified. (These letters were obtained without reg dept knowledge).

Follow up question:
Can a Class I device be cleared through the 510k process if a company would like to add diagnostic claims to its intended use? Obviously it is unlikely that the company would pursue this path, but I want to know if this is possible in theory.

Thanks again.