What is the difference btw RUO vs IUO for IVD in FDA guidance ?

[Brian K]

Hello,

What is the difference btw RUO vs IUO?

If I use a not-approved device for clinical validation under IDE, which term should be marked ?

Thanks

 

[chris1price]

Take a look at https://www.fda.gov/media/87374/download

An RUO product is an IVD product that is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to part 812. During the research phase of development, the focus of manufacturer-initiated studies is typically to evaluate design, limited-scale performance, and issues such as usability of the test.

An IUO product is an IVD product that is being shipped or delivered for product testing that is not subject to 21 CFR part 812 (with the exception of §812.119, Disqualification of clinical investigator) prior to full commercial marketing (for example, for testing of specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful)

Basically, RUO is an IVD that is still being developed. An IUO is undergoing tests to prove its efficacy and safety.

 

[Watchcat]

I was just digging into this last week and concluded it's a garbled mess. However, your situation seems fairly straightforward, if only because IDE stands for *investigational* device exemption, not research device exemption.

 

[Brian K]

Thanks for replies

I'm pretty sure that I can use IUO if my device is for clinical validation.

In contrast, if my device is not for clinical validation but for testing prior to full commercial marketing, can I also use IUO label? Even though it is not for clinical validation.

I just wanted to know whether IUO is applied to device only for clinical validation.

 

[Watchcat]

I just wanted to know whether IUO is applied to device only for clinical validation.

Then why did you ask which one should be used for a not-approved device for clinical validation under IDE?

 

[REG12]

Thanks for replies

I'm pretty sure that I can use IUO if my device is for clinical validation.

In contrast, if my device is not for clinical validation but for testing prior to full commercial marketing, can I also use IUO label? Even though it is not for clinical validation.

I just wanted to know whether IUO is applied to device only for clinical validation.

Good question which has been haunting me too. Would you say if your device is ready from design and development, tested for electrical safety then you can put IUO for further testing such as "testing between known (already diagnosed) healthy and diseased patients"? Further, can you put IUO label before getting FDA approval for IUO?
Cheers,
R

 

[Watchcat]

can you put IUO label before getting FDA approval for IUO?

As far as I know, FDA doesn't approve IUO. It does approve IDEs, though, and IUO is not a way around an IDE. I guess you can put IUO lablels all over your device any time you want, but you cannot use it as an investigational device without an IDE.

 

[Brian K]

Then why did you ask which one should be used for a not-approved device for clinical validation under IDE?

I think I made you confused. Sorry

My device will be provided for simple test prior to commercial market. But it is not under IDE regulation.
In this case, can I label IUO for my device?

Plus, when the device is IUO, can it be used in clinical practice to get some data?

 

[chris1price]

A IUO device is typically one intended to gather information for design validation, this can be in a clinical setting, ie gathering data from patients, but it can not be used to make clinical diagnosis or patient management. The FDA guidance is very clear on this.

 

[Watchcat]

I come back to 'I' stands for "investigational." If it is labeled IUO, it is an investigational device and it requires an investigational device exemption.

Whether it is provided for a simple test or a very complicated test has nothing to do with it.