CFR Part 830.50 - Changes that require use of a new device identifier

shimonv

shimonv

Trusted Information Resource
Hi Everyone,
I'd like to ask your opinion about what changes require a new UID.

The UDI FAQ Vol. 1 says: "The labeler has the responsibility to determine whether device upgrades or variations constitute different models or versions".

Do you think its possible to define in an SOP that only changes effecting the intended use or such that alter the fundamental technological characteristics are considered new version or model for the purpose of UDI?
This way bug fixes and enhancemnts will not require registration with GUDID.

Also, is it correct to say that from FDA's prospective that UDI replaces the manufacturer's P/N?

Thanks,
Shimon
 
Q

QA-Man

It is a good idea to define this in an SOP.

You could tie this to the decision to file a new 510(k), even for devices that do not require a new 510(k). It is just easier to tie it into an existing process rather than creating another.

I would say that the UDI replaces the part number (or will in the future). It is possible that two manufacturers have the same part number. If it is repackaged/relabeled, it might even be the same product. That can't happen with Unique Device Identifiers.
 
shimonv

shimonv

Trusted Information Resource
Thanks QA-Man.
I did some more research. The proposed rule more prescriptively defined the types of changes that resulted in a new version or mode.
This is what the original 830.50 said:

"If you make any of the following changes to a device that is required to bear a UDI on its label, the change results in a new version or model and you must assign a new device identifier to the new version or model:

(a) You change the specifications, performance, size, or composition of the device to an extent greater than the specified limits;

(b) You change the quantity in a device package or add a new device package;

(c) You make a change that could significantly affect the safety or effectiveness of the device;

(d) You change from a nonsterile package to a sterile package, or from a sterile package to a nonsterile package; or
(e) You relabel the device."

After receiving multiple comments the final rule gave labelers more flexibility to determine when a change to a device will require use of a new UDI.
This is what the final 830.50:

"(a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.
(b) Whenever you create a new device package, you must assign a new device identifier to the new device package."


So then it is up to us to determine when a new change should result in a new version or model, and SOP is a good way to do it.

Thanks,
Shimon
 
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