Hi guys,

I am hoping you can point me in the right direction, what, if any parts of
21CFR 820 apply to ehibition equipment.

My initial thoughts were 820.60 (Identification) and 820.65 (Traceability) but this seems to imply it is only for clinical devices

820.60

Each manufacturer... identifying product during all stages of reciept, production, distribution and installation

820.65

Each manufacturer of a device intended... to support life...

As our exhibition equipment is not able (functionality removed) to perform clinically, does this mean these clause do not apply to exhibition equipment and are there other subparts that do?

The same question please for 13485:2003

thx :thanx:

Do you manufacture the equipment that will be displayed?

If you do, there won't be any exemption in the system for the devices that will be placed in service.

I looked up the requirements and found: (emphasis mine) §820.60 Identification.
Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups.

§820.65 Traceability.
Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR. This tells us that the specific numbering requirements in 820.6 and 820.65 are intended for devices that will be placed in use.

However, I would err on the side of caution and define a method in your traceability procedures to identify the device or equipment as a sample: specifically not in-service. It helps that the item is disabled...

Anybody else please feel free to jump in and correct me.

Do you manufacture the equipment that will be displayed?

Yes... that is what is displayed is non functioning devices of what we make here

If you do, there won't be any exemption in the system for the devices that will be placed in service

The devices are purely for demonstration, and would not be placed in service

I looked up the requirements and found: (emphasis mine) This tells us that the specific numbering requirements in 820.6 and 820.65 are intended for devices that will be placed in use.

That was my take too

However, I would err on the side of caution and define a method in your traceability procedures to identify the device or equipment as a sample: specifically not in-service. It helps that the item is disabled

We currently use a documented release mechanism for exhibition items that shows what the device is, what it's intended use is at the exhibition, and requires that the device is identified as demonstration only. This mechanism is pert of the QS and controlled by QA.

This process for exhibitions is owned by the marketing group, and there are discussions going on as to whether or not there is value in going through a release process.

The value as I see it could be, we can demonstrate if required what was sent, when it was sent, it's purpose, and when it's returning.

Additionally if we are demonstrating in the USA there are reg's governing the promotion on non approved/licensed (no 510k) devices, so it is important how these devices are labelled.

To my knowledge this is not something that has been looked at in any of the inspections we have been through. And Marketing think it is overkill, hence my question.

Two points come to mind:

Make certain the non-functioning product is clearly marked as being demo only and not for clinical use (useful when a clinician takes it off the stand and tries to use it clinically!)

FDA are known to attend exhibitions and ask exhibitors about the use of a product for which it is not indicated; and then saying that unapproved marketing claims are being made.

Just a slight embellishment to wht chris1price said - any marketing literature that you hand out is potential for "claims." So be sure this material is well controlled (and understood!).