"RUO" (Research Use Only) Medical Device now seeking Clinic Use

[Republiccafe]

We have a medical device (Class I) registered for Research Use Only. Now we are using it in a general clinical setting. Should we seek another registration with FDA? Can the RUO registration and the clinic registration for the same device co-exist?

Thank you.

 

[MIREGMGR]

We have a medical device (Class I)...

What is the nature of your device...an IVD or a device related to IVDs?

Given that the point of RUO status is to avoid classification and associated compliance requirements that apply to patient-diagnostic-use devices, how have you established that your device is Class I?

...registered for Research Use Only.

What does "registered" refer to?

Now we are using it in a general clinical setting. Should we seek another registration with FDA? Can the RUO registration and the clinic registration for the same device co-exist?

Generally, sales of a device labeled Research Use Only to a user that the seller knows or should know will make clinical use of the device, constitute misbranding and are illegal.

Guessing that your device may be an IVD, the relevant guidance is http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm253307.htm.

 

[amjadrana]

Can a medical device that is not an IVD be used for "Research use only"? Would it be a medical device according to accepted definition, if it is not to be used for investigational purposes for the evaluation of safety and effectiveness?

 

[MIREGMGR]

As I think you're referencing, Investigational Device Exemption status is somewhat parallel to Research Use Only status; the former being used for non-IVD devices, the latter for IVDs.

An IDE-status device is a qualified device per definition; it however is not legally marketable for, or usable in, non-IDE clinical applications.

The IDE and RUO terms crossover to each other to a certain extent. There is a version of the Certificate to Foreign Government process (Form 3613c) that pertains to devices to be used outside of the US for research use, which certifies that the device(s) in question are legally usable for research in the US, but are not legal for US non-research clinical applications and are not intended for outside-US non-research clinical applications.

 

[amjadrana]

Thanks MIREGMGR for your reply. Maybe I did not put my question clearly. Can a medical device be an investigational device for clinical evaluation with an intended use and at the same time be a RESEARCH ONLY use not for clinical investigation for safety or effectiveness but only for research without any intended use? If it is for RESEARCH use only, would it fall under the definition of medical device and would other regulations like IDE be applicabel at all?

 

[MIREGMGR]

A scenario to make sure I understand the question:

1. Our hypothetical device is classified and marketable for clinical use in Diagnosis or Treatment of Disease/Condition X.

2. The same device is RUO or IDE for restricted use in some other application, not involving patients except possibly in the context of a qualified, supervised research program.

I think the answer is, the same marketed device cannot have both uses because it would not be permissible to label it both ways. However, the same core product could be provided to the market as two different devices, each with labeling for one of the the above applications.