S
What constitutes a Technical File "Family?"
When grouping devices together to create a family of products for Technical Files, rather than have a Technical File for each individual device, what constitutes a family and how is it determined if a device falls within a family?
We are creating a Technical File for a new family of Devices. These devices are products used in the mouth, but do not go past the pharynx, and they are intended for transient use. They are Class IIa devices using Rule 5 in the MDD (under invasive devices). These devices are products that connect to High Volume Evacuator systems (an active device). The intent of the device is to remove fluid from the mouth. There is no change made to the fluid, and it there is no fluid being administered into the body with this.
Now, I have been informed that they are considering adding yet another device for this line of products, however I am unsure if I can have it within the same Technical Family. The new device is a product that would connect the devices that go into the mouth to the HVE system itself, basically like a hose extension.
I have figured this new “extension” device would be Class IIa following Rule 11, now that the device itself is no longer invasive. (My only concern here is that Rule 11 is listed under “Additional rules applicable to Active Devices”. The concern is I am not positive this would be considered an active device, as the definition of an active device states…”medical devices intended to transmit energy, substances, or other elements between an active medical device and the patient, without any significant change are not considered to be active medical devices.” Although this indicates this device would not be an active device, I’m not seeing any other rule that could fit this product better.)
So in this case, I am wondering am I able to include the extension device into the same family, or would this end on in a family (and therefore Technical Family) of its own.
:
When grouping devices together to create a family of products for Technical Files, rather than have a Technical File for each individual device, what constitutes a family and how is it determined if a device falls within a family?
We are creating a Technical File for a new family of Devices. These devices are products used in the mouth, but do not go past the pharynx, and they are intended for transient use. They are Class IIa devices using Rule 5 in the MDD (under invasive devices). These devices are products that connect to High Volume Evacuator systems (an active device). The intent of the device is to remove fluid from the mouth. There is no change made to the fluid, and it there is no fluid being administered into the body with this.
Now, I have been informed that they are considering adding yet another device for this line of products, however I am unsure if I can have it within the same Technical Family. The new device is a product that would connect the devices that go into the mouth to the HVE system itself, basically like a hose extension.
I have figured this new “extension” device would be Class IIa following Rule 11, now that the device itself is no longer invasive. (My only concern here is that Rule 11 is listed under “Additional rules applicable to Active Devices”. The concern is I am not positive this would be considered an active device, as the definition of an active device states…”medical devices intended to transmit energy, substances, or other elements between an active medical device and the patient, without any significant change are not considered to be active medical devices.” Although this indicates this device would not be an active device, I’m not seeing any other rule that could fit this product better.)
So in this case, I am wondering am I able to include the extension device into the same family, or would this end on in a family (and therefore Technical Family) of its own.
:
