Regulatory Open Forum

All, I've come across a problem in which I don't have any experience and require some assistance. 

My company has a contract manufacturer that builds a "kit" that contains the following components with their own serial numbers and manufacturing dates: 1 reader, 2 sensors, and 2 docking stations. This kit is compiled under a specification number and the outer label contains this number plus all of the component serial numbers. The DHR for this "kit" contains all of the component documentation collectively and each component is listed together on the CoC.

We also manufacture spare components that replace components within the "kit". This spare component has its own DHR and is manufactured under its own specification.

This is the conundrum...

Kits that are returned from a customer are eligible for restock if it passes incoming inspection criteria. However, if we receive a returned kit from a customer with the original components except for one component...let's say the sensor, which is a spare that was sent to the customer to replace the original. The kit is okay for restocking and we need to incorporate the spare sensor into the original kit.

I'm unsure of how to handle this from a documentation perspective. We would prefer to have the contract manufacturer rework the spare sensor into the kit and generate a new CoC and a new outer packaging label depicting the spare sensor's serial number. However, it seems as if traceability of the spare sensor would be lost because it would be incorporated into a different DHR. I thought about incorporating a memo to file for the spare sensor DHR and point it to the kit DHR; however, this seems tedious and could get confusing if multiple components are swapped in and out of kits.

Any suggestions of the best way to handle components, the documentation and labelling that are swapped out of kits? Note, we do not issue a kit serial number, but use the reader serial number to identify a kit.

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Tonia,
You don't mention anything about unique device identifiers (UDI). This is not only a regulatory requirement for all medical devices, but can also be used for internal identification and traceability purposes. For example, the KIT is assigned a UDI, where the lot or serial # contained in the production identifier (PI) portion of the UDI reflects all component parts contained within. Each component also has a UDI with it's own serial # for the PI. ​​​I have attached a diagram to better illustrate this.

Additionally, it is important to use terminology appropriately per the FDA definitions (note - OUS definitions may differ slightly):

• Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.

• Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device's
  performance, safety specifications, or intended use.

• Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic
  upkeep for the current owner of the device.

• Rework: Action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. (y

• Accessory: A device that is intended to support, supplement, and/or augment the performance of one or more parent devices.
  • Support means to enable or facilitate the device to perform according to its intended use
  • Supplement is defined as adding a new function or new way of using the device
  • Augment improves the performance of the device by enabling the device to perform its intended use more safely or effectively

• Spare Part: Supplied for replacement of existing components of a device and do not change the characteristics or affect the performance of a device

• Component: Any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

With limited knowledge of your devices, from what you have written it seems that what you are calling 'components' and 'spare parts' might actually be 'accessories', and 'rework' might actually be 'refurbish.'

Hope this helps!

------------------------------
Lena Cordie-Bancroft
Victoria MN
United States
------------------------------

Original Message:
Sent: 04-Sep-2019 15:22
From: Tonia Bryant
Subject: Components, Kits, DHR documentation/labeling issues

All, I've come across a problem in which I don't have any experience and require some assistance.

My company has a contract manufacturer that builds a "kit" that contains the following components with their own serial numbers and manufacturing dates: 1 reader, 2 sensors, and 2 docking stations. This kit is compiled under a specification number and the outer label contains this number plus all of the component serial numbers. The DHR for this "kit" contains all of the component documentation collectively and each component is listed together on the CoC.

We also manufacture spare components that replace components within the "kit". This spare component has its own DHR and is manufactured under its own specification.

This is the conundrum...

Kits that are returned from a customer are eligible for restock if it passes incoming inspection criteria. However, if we receive a returned kit from a customer with the original components except for one component...let's say the sensor, which is a spare that was sent to the customer to replace the original. The kit is okay for restocking and we need to incorporate the spare sensor into the original kit.

I'm unsure of how to handle this from a documentation perspective. We would prefer to have the contract manufacturer rework the spare sensor into the kit and generate a new CoC and a new outer packaging label depicting the spare sensor's serial number. However, it seems as if traceability of the spare sensor would be lost because it would be incorporated into a different DHR. I thought about incorporating a memo to file for the spare sensor DHR and point it to the kit DHR; however, this seems tedious and could get confusing if multiple components are swapped in and out of kits.

Any suggestions of the best way to handle components, the documentation and labelling that are swapped out of kits? Note, we do not issue a kit serial number, but use the reader serial number to identify a kit.

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Hi Lena,

Thank you for your response.

Our device is Class I and we're at the beginning of putting together our UDI project. Each component within the system kit will have their own UDI numbers since each component may be replaced with a spare part (our spares are not accessories). This will provide traceability to each individual component.

Also, thank you for the attachment. It helps greatly and I can formulate a system based off the flowchart. 

Cheers!

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Original Message:
Sent: 04-Sep-2019 21:15
From: Lena Cordie-Bancroft
Subject: Components, Kits, DHR documentation/labeling issues

Tonia,
You don't mention anything about unique device identifiers (UDI). This is not only a regulatory requirement for all medical devices, but can also be used for internal identification and traceability purposes. For example, the KIT is assigned a UDI, where the lot or serial # contained in the production identifier (PI) portion of the UDI reflects all component parts contained within. Each component also has a UDI with it's own serial # for the PI. ​​​I have attached a diagram to better illustrate this.

Additionally, it is important to use terminology appropriately per the FDA definitions (note - OUS definitions may differ slightly):

• Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.

• Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device's
  performance, safety specifications, or intended use.

• Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic
  upkeep for the current owner of the device.

• Rework: Action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. (y

• Accessory: A device that is intended to support, supplement, and/or augment the performance of one or more parent devices.
  • Support means to enable or facilitate the device to perform according to its intended use
  • Supplement is defined as adding a new function or new way of using the device
  • Augment improves the performance of the device by enabling the device to perform its intended use more safely or effectively

• Spare Part: Supplied for replacement of existing components of a device and do not change the characteristics or affect the performance of a device

• Component: Any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

With limited knowledge of your devices, from what you have written it seems that what you are calling 'components' and 'spare parts' might actually be 'accessories', and 'rework' might actually be 'refurbish.'

Hope this helps!

------------------------------
Lena Cordie-Bancroft
Victoria MN
United States

Original Message:
Sent: 04-Sep-2019 15:22
From: Tonia Bryant
Subject: Components, Kits, DHR documentation/labeling issues

All, I've come across a problem in which I don't have any experience and require some assistance.

My company has a contract manufacturer that builds a "kit" that contains the following components with their own serial numbers and manufacturing dates: 1 reader, 2 sensors, and 2 docking stations. This kit is compiled under a specification number and the outer label contains this number plus all of the component serial numbers. The DHR for this "kit" contains all of the component documentation collectively and each component is listed together on the CoC.

We also manufacture spare components that replace components within the "kit". This spare component has its own DHR and is manufactured under its own specification.

This is the conundrum...

Kits that are returned from a customer are eligible for restock if it passes incoming inspection criteria. However, if we receive a returned kit from a customer with the original components except for one component...let's say the sensor, which is a spare that was sent to the customer to replace the original. The kit is okay for restocking and we need to incorporate the spare sensor into the original kit.

I'm unsure of how to handle this from a documentation perspective. We would prefer to have the contract manufacturer rework the spare sensor into the kit and generate a new CoC and a new outer packaging label depicting the spare sensor's serial number. However, it seems as if traceability of the spare sensor would be lost because it would be incorporated into a different DHR. I thought about incorporating a memo to file for the spare sensor DHR and point it to the kit DHR; however, this seems tedious and could get confusing if multiple components are swapped in and out of kits.

Any suggestions of the best way to handle components, the documentation and labelling that are swapped out of kits? Note, we do not issue a kit serial number, but use the reader serial number to identify a kit.

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Great! Not sure I answered your question though. I'm sure there's a way to do it. Let me know if you need any help with your UDI plan!

------------------------------
Lena Cordie-Bancroft
Victoria MN
United States
------------------------------

Original Message:
Sent: 05-Sep-2019 09:14
From: Tonia Bryant
Subject: Components, Kits, DHR documentation/labeling issues

Hi Lena,

Thank you for your response.

Our device is Class I and we're at the beginning of putting together our UDI project. Each component within the system kit will have their own UDI numbers since each component may be replaced with a spare part (our spares are not accessories). This will provide traceability to each individual component.

Also, thank you for the attachment. It helps greatly and I can formulate a system based off the flowchart.

Cheers!

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States

Original Message:
Sent: 04-Sep-2019 21:15
From: Lena Cordie-Bancroft
Subject: Components, Kits, DHR documentation/labeling issues

Tonia,
You don't mention anything about unique device identifiers (UDI). This is not only a regulatory requirement for all medical devices, but can also be used for internal identification and traceability purposes. For example, the KIT is assigned a UDI, where the lot or serial # contained in the production identifier (PI) portion of the UDI reflects all component parts contained within. Each component also has a UDI with it's own serial # for the PI. ​​​I have attached a diagram to better illustrate this.

Additionally, it is important to use terminology appropriately per the FDA definitions (note - OUS definitions may differ slightly):

• Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.

• Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device's
  performance, safety specifications, or intended use.

• Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic
  upkeep for the current owner of the device.

• Rework: Action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. (y

• Accessory: A device that is intended to support, supplement, and/or augment the performance of one or more parent devices.
  • Support means to enable or facilitate the device to perform according to its intended use
  • Supplement is defined as adding a new function or new way of using the device
  • Augment improves the performance of the device by enabling the device to perform its intended use more safely or effectively

• Spare Part: Supplied for replacement of existing components of a device and do not change the characteristics or affect the performance of a device

• Component: Any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

With limited knowledge of your devices, from what you have written it seems that what you are calling 'components' and 'spare parts' might actually be 'accessories', and 'rework' might actually be 'refurbish.'

Hope this helps!

------------------------------
Lena Cordie-Bancroft
Victoria MN
United States

Original Message:
Sent: 04-Sep-2019 15:22
From: Tonia Bryant
Subject: Components, Kits, DHR documentation/labeling issues

All, I've come across a problem in which I don't have any experience and require some assistance.

My company has a contract manufacturer that builds a "kit" that contains the following components with their own serial numbers and manufacturing dates: 1 reader, 2 sensors, and 2 docking stations. This kit is compiled under a specification number and the outer label contains this number plus all of the component serial numbers. The DHR for this "kit" contains all of the component documentation collectively and each component is listed together on the CoC.

We also manufacture spare components that replace components within the "kit". This spare component has its own DHR and is manufactured under its own specification.

This is the conundrum...

Kits that are returned from a customer are eligible for restock if it passes incoming inspection criteria. However, if we receive a returned kit from a customer with the original components except for one component...let's say the sensor, which is a spare that was sent to the customer to replace the original. The kit is okay for restocking and we need to incorporate the spare sensor into the original kit.

I'm unsure of how to handle this from a documentation perspective. We would prefer to have the contract manufacturer rework the spare sensor into the kit and generate a new CoC and a new outer packaging label depicting the spare sensor's serial number. However, it seems as if traceability of the spare sensor would be lost because it would be incorporated into a different DHR. I thought about incorporating a memo to file for the spare sensor DHR and point it to the kit DHR; however, this seems tedious and could get confusing if multiple components are swapped in and out of kits.

Any suggestions of the best way to handle components, the documentation and labelling that are swapped out of kits? Note, we do not issue a kit serial number, but use the reader serial number to identify a kit.

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------