Is UDI required for Spare Parts?

[shimonv]

Hi Guys,
The title pretty much describes by question.
From a logical prospective, there is no logic in applying UDI on spare parts, but the the definition of a device (21 USC 321(h)) includes components as well as accessories. I'm okay with accessories, but component (21 CFR 820.3) can mean any field replacement unit. What am I missing here?

Thanks,
Shimon

 

[Ronen E]

Hi Guys,
The title pretty much describes by question.
From a logical prospective, there is no logic in applying UDI on spare parts, but the the definition of a device (21 USC 321(h)) includes components as well as accessories. I'm okay with accessories, but component (21 CFR 820.3) can mean any field replacement unit. What am I missing here?

Thanks,
Shimon

As far as my understanding goes, if your components are to be sold directly to end users as replacement parts they do need a UDI; however, I couldn't track such a clear statement in FDA regulations or guidance, and the general atmosphere I get from non-government players is that spare/replacement parts don't need a UDI (though no-one seems to point out an FDA source to back it).

Ronen.

 

[shimonv]

Thanks Ronen,
It seems that this is one of those gray areas where the written regulation is too strict and the industry practice is the acceptable practice. I found this quotation on the net, of courser its not official but a good principle to follow:

"Spare parts supplied for replacement of existing components of a device, the conformity of which has already been established, are not medical devices. If spare parts, however, change significantly the characteristics or performances of a device with regard to its already established conformity, such spare parts are to be considered as devices in their own right."

BR,
Shimon

 

[Ronen E]

Thanks Ronen,
It seems that this is one of those gray areas where the written regulation is too strict and the industry practice is the acceptable practice. I found this quotation on the net, of courser its not official but a good principle to follow:

"Spare parts supplied for replacement of existing components of a device, the conformity of which has already been established, are not medical devices. If spare parts, however, change significantly the characteristics or performances of a device with regard to its already established conformity, such spare parts are to be considered as devices in their own right."

BR,
Shimon

I found it too. Unfortunately it's EU-related and it's well-known that on some issues EU and US approaches (and sometimes practices) differ.

 

[Asia78]

Hi, coming to the same question. After a couple of years from the initial question I am wondering if a hardware component needs a udi in the USA. Thanks