Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

My client wishes to offer a replacement warranty on their Rx device.  Does anyone have guidance how they can compliantly distribute prescription devices since they are not licensed as a pharmacy or DME supplier? I know many companies offer similar warranties, so there has to be a way to do so.  Thanks in advance for your help.

Hello Anon,

Sorry not understanding the context well, a medical device manufacturer does not need to be licensed necessarily as a pharmacy to sell medical devices.  In fact, it is more the opposite where the manufacturer needs to confirm who they are selling the product, can be a purchaser of the product.  As example, during the sales ordering process there is a check, confirmation, registration, etc., of the customer as a hospital, clinic, or a medical professional.  In some cases, hospitals have on record name(s) of healthcare professionals in order to purchase prescription medical devices.  Now with that said, depending on the country or even the State/region in a country sometimes there are additional registration or licensure which needs to be obtained be a manufacturer and sell medical devices domestically, internationally, or both.  Typically for replacement warranty, the customer would be sending back the original device which would be replaced and/or repaired to be sent back to the customer.  Hopefully that helps, but probably need some more information to fully understand the situation.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Jan-2022 20:40
From: Anonymous Member
Subject: Warranty replacements for Rx device

This message was posted by a user wishing to remain anonymous

My client wishes to offer a replacement warranty on their Rx device.  Does anyone have guidance how they can compliantly distribute prescription devices since they are not licensed as a pharmacy or DME supplier? I know many companies offer similar warranties, so there has to be a way to do so.  Thanks in advance for your help.

This message was posted by a user wishing to remain anonymous

Thanks, Richard.
Sharing more details for clarity.

In this case, the device is a disposable for home use, only in the U.S.  There are no hospitals involved.  

The manufacturer does not want to request the return of faulty devices.  It is understood that a small % of devices may experience issues with the batteries or sensors, and manufacturer just wishes to send out replacements.  

Does the manufacturer have a duty to verify the prescription? If sending a prescription device directly to a patient is manufacturer required to obtain any state licensure? 

TIA

Original Message:
Sent: 13-Jan-2022 20:40
From: Anonymous Member
Subject: Warranty replacements for Rx device

This message was posted by a user wishing to remain anonymous

My client wishes to offer a replacement warranty on their Rx device.  Does anyone have guidance how they can compliantly distribute prescription devices since they are not licensed as a pharmacy or DME supplier? I know many companies offer similar warranties, so there has to be a way to do so.  Thanks in advance for your help.

Hello,

Ok I understand the situation a little better.  This would be instance of a prescription device which is intended for home-use - taking home by the user after they get the device from their healthcare professional.  In my experience, the manufacturer usually does not verify the prescription in this case.  I guess just by the pure fact the user/patient has the device, then it has been generally assumed it has been prescribed to them.  In most common approach, this would be traceable through the Device History Record, sales order process, and then the complaints database which would tie everything together.  As example. this device would have a lot number from the manufacturing, the lot numbers can be traced to who ordered products, and then the lot number recorded in the complaint database.  Then the replacement products would also have a order fulfilment associated with it, so again the traceability.  Hopefully gives some ideas, having the traceability is what ties everything together - not necessarily proving there is some prescription sheet in place with the user/patient.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 19-Jan-2022 05:42
From: Anonymous Member
Subject: Warranty replacements for Rx device


This message was posted by a user wishing to remain anonymous

Thanks, Richard.
Sharing more details for clarity.

In this case, the device is a disposable for home use, only in the U.S.  There are no hospitals involved.  

The manufacturer does not want to request the return of faulty devices.  It is understood that a small % of devices may experience issues with the batteries or sensors, and manufacturer just wishes to send out replacements.  

Does the manufacturer have a duty to verify the prescription? If sending a prescription device directly to a patient is manufacturer required to obtain any state licensure?

TIA

Original Message:
Sent: 13-Jan-2022 20:40
From: Anonymous Member
Subject: Warranty replacements for Rx device

This message was posted by a user wishing to remain anonymous

My client wishes to offer a replacement warranty on their Rx device.  Does anyone have guidance how they can compliantly distribute prescription devices since they are not licensed as a pharmacy or DME supplier? I know many companies offer similar warranties, so there has to be a way to do so.  Thanks in advance for your help.

This message was posted by a user wishing to remain anonymous

Thanks again, Richard.
 Very helpful.
Original Message:
Sent: 20-Jan-2022 05:02
From: Richard Vincins
Subject: Warranty replacements for Rx device

Hello,

Ok I understand the situation a little better.  This would be instance of a prescription device which is intended for home-use - taking home by the user after they get the device from their healthcare professional.  In my experience, the manufacturer usually does not verify the prescription in this case.  I guess just by the pure fact the user/patient has the device, then it has been generally assumed it has been prescribed to them.  In most common approach, this would be traceable through the Device History Record, sales order process, and then the complaints database which would tie everything together.  As example. this device would have a lot number from the manufacturing, the lot numbers can be traced to who ordered products, and then the lot number recorded in the complaint database.  Then the replacement products would also have a order fulfilment associated with it, so again the traceability.  Hopefully gives some ideas, having the traceability is what ties everything together - not necessarily proving there is some prescription sheet in place with the user/patient.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 19-Jan-2022 05:42
From: Anonymous Member
Subject: Warranty replacements for Rx device


This message was posted by a user wishing to remain anonymous

Thanks, Richard.
Sharing more details for clarity.

In this case, the device is a disposable for home use, only in the U.S.  There are no hospitals involved.  

The manufacturer does not want to request the return of faulty devices.  It is understood that a small % of devices may experience issues with the batteries or sensors, and manufacturer just wishes to send out replacements.  

Does the manufacturer have a duty to verify the prescription? If sending a prescription device directly to a patient is manufacturer required to obtain any state licensure?

TIA

Original Message:
Sent: 13-Jan-2022 20:40
From: Anonymous Member
Subject: Warranty replacements for Rx device

This message was posted by a user wishing to remain anonymous

My client wishes to offer a replacement warranty on their Rx device.  Does anyone have guidance how they can compliantly distribute prescription devices since they are not licensed as a pharmacy or DME supplier? I know many companies offer similar warranties, so there has to be a way to do so.  Thanks in advance for your help.