Regulatory Open Forum

Hello, 

It's always been my understanding that labeling devices for clinical trials and research as RUO or IUO depends on what the purpose on the trial/research is. I was always taught that any device used to support regulatory submissions, clinical claims, intended uses or is subject to 21 CFR 812, must be labeled as IUO. If you're conducting a research study or anything in lab development which is not subject to part 812, you can use RUO. Currently, we have a device that needs to be shipped to the patients home for specimen collection and then shipped to our laboratory for testing. This is a research study and will not be used to support any regulatory submission. I believe this still falls under RUO even through we are shipping a collection kit to a patients home. We do not need to de do device accountability because this is for research use only. Was curious what other regulatory folks thought? ... In addition, if we did a clinical trial that was only subject to GCP because we were only collection information for research purposes, I believe this would still be RUO.

Thanks!

For IVDs there are two cases. The device is subject to Part 812 or the device is not subject to part 812. Start with 809.10(c). 809.10(c)(1) covers applicability to Part 812 while 809.10(c)(2) covers not applicable to Part 812.

It has two cases.

<o:p></o:p>809.10(c)(1)(i) For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed: "For Research Use Only. Not for use in diagnostic procedures".

809.10(c)(1)(ii) For a product being shipped or delivered for product testing prior to full commercial marketing …, all labeling bears the statement, prominently placed: "For Investigational Use Only. The performance characteristics of this product have not been established".

Unfortunately, there is a colloquial meaning of RUO that pertains to stuff used in a research project, and not for diagnostic purposes. These are not medical devices. For (a silly) example, supposed your research project were to collect navel lint specimens after a person had eaten turnips. You want to determine if there is a correlation between the amount of navel lint, consumption of turnips, and consumption of rutabagas. You would send out lint specimen collection products. Some labs would label them as Research Use Only, RUO, suggesting the collection is not for diagnostic purposes. These products are unlike, for example, blood collection tubes used by a lab to determine A1C. In this case, neither Part 809 nor Part 812 would apply.<o:p></o:p>

Hello, 

It's always been my understanding that labeling devices for clinical trials and research as RUO or IUO depends on what the purpose on the trial/research is. I was always taught that any device used to support regulatory submissions, clinical claims, intended uses or is subject to 21 CFR 812, must be labeled as IUO. If you're conducting a research study or anything in lab development which is not subject to part 812, you can use RUO. Currently, we have a device that needs to be shipped to the patients home for specimen collection and then shipped to our laboratory for testing. This is a research study and will not be used to support any regulatory submission. I believe this still falls under RUO even through we are shipping a collection kit to a patients home. We do not need to de do device accountability because this is for research use only. Was curious what other regulatory folks thought? ... In addition, if we did a clinical trial that was only subject to GCP because we were only collection information for research purposes, I believe this would still be RUO.

Thanks!