Regulatory Open Forum

Hi all,

1/ I am wondering if for the US market there is an equivalent to"Reasearch Use Only" that it sometimes used for IVD reagents but for medical devices ? If so are they regulated by FDA or any other agencies ?

2/ I am also asking if we can add "Non medical features" into a medical device that is one main MD claim and extra-features that are available but without any medical claims ?

Thank you.

I'll address the first question only.

You need to be very cautious with the phrase "Research Use Only" in the context of medical devices (IVDs) in the US.

RUO has two meanings. One is reagents not intended for use in humans. For example, your company might sell reagents with the intention of research on animals, such as metabolic paths in mice. FDA does not regulate these products as devices.

The other is a development stage for an IVD. These are regulated by FDA, but not available for diagnostic use on humans because they are under development.

I infer, however, that your question is about medical devices that are not IVDs. In this case, the development stage might include human trials so the products are subject to an "Investigational device exemption" commonly called an IVD.

Hi all,

1/ I am wondering if for the US market there is an equivalent to"Reasearch Use Only" that it sometimes used for IVD reagents but for medical devices ? If so are they regulated by FDA or any other agencies ?

2/ I am also asking if we can add "Non medical features" into a medical device that is one main MD claim and extra-features that are available but without any medical claims ?

Thank you.

Hello Quang,

Research Use Only (RUO) products are exactly that - research use only.  This applies to medical devices and IVD medical devices - so if a research use only - would not be used on, in, or with a patient.  IVDs are a little different in the RUO area because some companies use left-over or de-identified specimens in purely development work as Dan mentions.  Regardless, a research device would not be used with a human or using human specimens reporting back to the patient.

There have been some other posts on the forum concerning your second question which could review.  There can be features or options on medical devices which are not considered "medical" though it is important proper marketing statements and any claims being made are clear the feature or use are not considered a medical device.  Then also be very careful about having RUO features or options on a regular device.  I had experience with a company that had the RUO and regular modes on the same device - the US FDA did not like that very much.

I'll address the first question only.

You need to be very cautious with the phrase "Research Use Only" in the context of medical devices (IVDs) in the US.

RUO has two meanings. One is reagents not intended for use in humans. For example, your company might sell reagents with the intention of research on animals, such as metabolic paths in mice. FDA does not regulate these products as devices.

The other is a development stage for an IVD. These are regulated by FDA, but not available for diagnostic use on humans because they are under development.

I infer, however, that your question is about medical devices that are not IVDs. In this case, the development stage might include human trials so the products are subject to an "Investigational device exemption" commonly called an IVD.

Hi all,

1/ I am wondering if for the US market there is an equivalent to"Reasearch Use Only" that it sometimes used for IVD reagents but for medical devices ? If so are they regulated by FDA or any other agencies ?

2/ I am also asking if we can add "Non medical features" into a medical device that is one main MD claim and extra-features that are available but without any medical claims ?

Thank you.