Regulatory Open Forum

Hello Group, 

We are shipping genetic testing reagent kits (non-effective IVDs) to sites in the US and France for beta testing in our design and development process. That is, the data produced will not directly support final performance evaluation/validations, but will be used in the final phase of optimization for our kit before we enter the design lock and the V&V phase. 

In the past (ie before our current RA team), the company used "For Evaluation Use Only" to distribute this type of kit in the US and we used "For Evaluation Purposes Only" for distribution in the EU. I'm not finding these terms anywhere in either US or EU guidance or regulation. I am finding RUO vs IUO FDA guidance and I found RUO vs Performance Evaluation guidance in MEDDEV. 

What labeling is in compliance?? I'm pulling my hair out over here scouring the internet for EUO guidance. TIA!! 

Hi, you should be using either RUO or IUO.  

Research use only if you are in the research phase (prior to clinical trial), which is what this sounds like.  IUO if you are in the investigational clinical trial phase.  If you need more help feel free to reach out! 

Hi Anon,

with respect to the EU: The MEDDEV guidance is based on the IVDD and is of limited or no value for the IVDR (Regulation (EU) 2017/746). While there are MDCG guidance documents for performance studies (see here), I do not remember them covering the RUO vs. performance study question.

As far as I can see the correct labelling would depend on whether your study fulfills the definition for a performance study under the IVDR Article 1(42): "A study undertaken to establish or confirm the analytical or clinical performance of a device". This question is of course also important to decide what kind of authorization might be required. In your case it seems to me that you are not in a purely research phase of the design and development (e.g. establishing general scientific validity), but in the course of establishing analytical and clinical performance. So this would probably already be covered by the performance study definition (especially if the respective data later will be used in the context of your analytical and clinical performance evaluations and reports). I assume that for the study in France some kind of ethics board or comparable will be involved. They should have an opinion on that.

Best regards

Christoph