Regulatory Open Forum

Hello,

I'm aware of the IVD guidance that exempts some IVDs from IDE requirements if they are RUO or IUO IVDs, and require labeling the IVDs as such (RUO or IOU). Medical devices can be investigational devices if they are not approved/cleared.

Can medical devices (non-IVD) be research use only devices? What is the criteria for that? Is there any guidance about that? I would presume that they cannot be used on patients unless part of an IDE or similar pathway as investigational devices.

Thanks
Hiral

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Hi Hiral,  it amounts to the same requirement for both.

RUO IVDs can be used for either genuine research, i;e; assays on non-clinical samples where no diagnostic advice is returned to patient or treating physician for clinical action or on Investigational Use IVDs can be used on actual patient samples within the confines of a clinical trial.

Medical devices similarly can be for Investigational Use Only - again in a properly approved clinical trial.  Other than that they can't be used for therapeutic purposes on patients unless they are cleared/approved or Class I exempt..

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com
------------------------------

Original Message:
Sent: 02-Apr-2020 14:09
From: Hiral Dutia
Subject: Medical device (non-IVD) RUOs

Hello,

I'm aware of the IVD guidance that exempts some IVDs from IDE requirements if they are RUO or IUO IVDs, and require labeling the IVDs as such (RUO or IOU). Medical devices can be investigational devices if they are not approved/cleared.

Can medical devices (non-IVD) be research use only devices? What is the criteria for that? Is there any guidance about that? I would presume that they cannot be used on patients unless part of an IDE or similar pathway as investigational devices.

Thanks
Hiral

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Hello Hiral,

There is actually no designation between IUO and RUO for a pure medical device - they are just all considered investigational.  Though the distinction can be made with your device in labelling, i.e. you can put information on the device itself and IFU the device is used for research purposes only, but you would label the same as is specified in the regulation.  For me the main distinction between investigation devices and research devices is investigation devices are used on/with/in patients and research devices are not used with patients.  I know there are a lot of exceptions - I just use that as a simple distinction.  The thought process why there is no "research" designation with medical devices because they would always be used with a patient, therefore needing all the GCP items in place, i.e. informed consent.  Whereas IVDs can be research because they can use leftover samples, de-identified samples, or even non-human materials to determine whether they work or not.  That is a little harder to do with pure medical devices because harder to determine if you can not use with a patient.  Think of research as your non-clinical bench performance testing, thus again why there is really no designation for RUO of medical devices.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 03-Apr-2020 00:57
From: Arthur Brandwood
Subject: Medical device (non-IVD) RUOs

Hi Hiral,  it amounts to the same requirement for both.

RUO IVDs can be used for either genuine research, i;e; assays on non-clinical samples where no diagnostic advice is returned to patient or treating physician for clinical action or on Investigational Use IVDs can be used on actual patient samples within the confines of a clinical trial.

Medical devices similarly can be for Investigational Use Only - again in a properly approved clinical trial.  Other than that they can't be used for therapeutic purposes on patients unless they are cleared/approved or Class I exempt..

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 02-Apr-2020 14:09
From: Hiral Dutia
Subject: Medical device (non-IVD) RUOs

Hello,

I'm aware of the IVD guidance that exempts some IVDs from IDE requirements if they are RUO or IUO IVDs, and require labeling the IVDs as such (RUO or IOU). Medical devices can be investigational devices if they are not approved/cleared.

Can medical devices (non-IVD) be research use only devices? What is the criteria for that? Is there any guidance about that? I would presume that they cannot be used on patients unless part of an IDE or similar pathway as investigational devices.

Thanks
Hiral

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Thank you Arthur and Richard. I couldn't think of a scenario in which true medical devices would be research only and not used on a patient so I'm glad to hear you both confirm that. Makes complete sense that medical devices can be only investigational (barring unusual cases and exceptions I suppose).

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 03-Apr-2020 01:28
From: Richard Vincins
Subject: Medical device (non-IVD) RUOs

Hello Hiral,

There is actually no designation between IUO and RUO for a pure medical device - they are just all considered investigational.  Though the distinction can be made with your device in labelling, i.e. you can put information on the device itself and IFU the device is used for research purposes only, but you would label the same as is specified in the regulation.  For me the main distinction between investigation devices and research devices is investigation devices are used on/with/in patients and research devices are not used with patients.  I know there are a lot of exceptions - I just use that as a simple distinction.  The thought process why there is no "research" designation with medical devices because they would always be used with a patient, therefore needing all the GCP items in place, i.e. informed consent.  Whereas IVDs can be research because they can use leftover samples, de-identified samples, or even non-human materials to determine whether they work or not.  That is a little harder to do with pure medical devices because harder to determine if you can not use with a patient.  Think of research as your non-clinical bench performance testing, thus again why there is really no designation for RUO of medical devices.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 03-Apr-2020 00:57
From: Arthur Brandwood
Subject: Medical device (non-IVD) RUOs

Hi Hiral,  it amounts to the same requirement for both.

RUO IVDs can be used for either genuine research, i;e; assays on non-clinical samples where no diagnostic advice is returned to patient or treating physician for clinical action or on Investigational Use IVDs can be used on actual patient samples within the confines of a clinical trial.

Medical devices similarly can be for Investigational Use Only - again in a properly approved clinical trial.  Other than that they can't be used for therapeutic purposes on patients unless they are cleared/approved or Class I exempt..

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 02-Apr-2020 14:09
From: Hiral Dutia
Subject: Medical device (non-IVD) RUOs

Hello,

I'm aware of the IVD guidance that exempts some IVDs from IDE requirements if they are RUO or IUO IVDs, and require labeling the IVDs as such (RUO or IOU). Medical devices can be investigational devices if they are not approved/cleared.

Can medical devices (non-IVD) be research use only devices? What is the criteria for that? Is there any guidance about that? I would presume that they cannot be used on patients unless part of an IDE or similar pathway as investigational devices.

Thanks
Hiral

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message------

Thank you Arthur and Richard. I couldn't think of a scenario in which true medical devices would be research only and not used on a patient so I'm glad to hear you both confirm that. Makes complete sense that medical devices can be only investigational (barring unusual cases and exceptions I suppose).

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Hi Hiral,

We use the RUO Designation when shipping devices from one location to another that are only to be used in in-vitro testing.  RUO are also "Not for Human Use".  They are not i"nvestigational use" as that is only reserved for devices to be used on patients under an IDE or for an NSR study.  This is usually for design verification testing.

------------------------------
Lee Leichter RAC, MBA
President P/L Biomedical
Fort Myers FL
United States
------------------------------

Original Message:
Sent: 03-Apr-2020 12:11
From: Hiral Dutia
Subject: Medical device (non-IVD) RUOs

Thank you Arthur and Richard. I couldn't think of a scenario in which true medical devices would be research only and not used on a patient so I'm glad to hear you both confirm that. Makes complete sense that medical devices can be only investigational (barring unusual cases and exceptions I suppose).

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 03-Apr-2020 01:28
From: Richard Vincins
Subject: Medical device (non-IVD) RUOs

Hello Hiral,

There is actually no designation between IUO and RUO for a pure medical device - they are just all considered investigational.  Though the distinction can be made with your device in labelling, i.e. you can put information on the device itself and IFU the device is used for research purposes only, but you would label the same as is specified in the regulation.  For me the main distinction between investigation devices and research devices is investigation devices are used on/with/in patients and research devices are not used with patients.  I know there are a lot of exceptions - I just use that as a simple distinction.  The thought process why there is no "research" designation with medical devices because they would always be used with a patient, therefore needing all the GCP items in place, i.e. informed consent.  Whereas IVDs can be research because they can use leftover samples, de-identified samples, or even non-human materials to determine whether they work or not.  That is a little harder to do with pure medical devices because harder to determine if you can not use with a patient.  Think of research as your non-clinical bench performance testing, thus again why there is really no designation for RUO of medical devices.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 03-Apr-2020 00:57
From: Arthur Brandwood
Subject: Medical device (non-IVD) RUOs

Hi Hiral,  it amounts to the same requirement for both.

RUO IVDs can be used for either genuine research, i;e; assays on non-clinical samples where no diagnostic advice is returned to patient or treating physician for clinical action or on Investigational Use IVDs can be used on actual patient samples within the confines of a clinical trial.

Medical devices similarly can be for Investigational Use Only - again in a properly approved clinical trial.  Other than that they can't be used for therapeutic purposes on patients unless they are cleared/approved or Class I exempt..

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 02-Apr-2020 14:09
From: Hiral Dutia
Subject: Medical device (non-IVD) RUOs

Hello,

I'm aware of the IVD guidance that exempts some IVDs from IDE requirements if they are RUO or IUO IVDs, and require labeling the IVDs as such (RUO or IOU). Medical devices can be investigational devices if they are not approved/cleared.

Can medical devices (non-IVD) be research use only devices? What is the criteria for that? Is there any guidance about that? I would presume that they cannot be used on patients unless part of an IDE or similar pathway as investigational devices.

Thanks
Hiral

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Hi Hiral,

I Agree with most of the previous replies and especially with Richard.
There are many cases where you can distribute a MD which is not cleared/approved or without CE, such as for pre-clinical studies and clinical studies, exhibitions, etc.
It must be clearly stated on the label the purpose and that it is not for human use. This is the only requirement.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 02-Apr-2020 14:09
From: Hiral Dutia
Subject: Medical device (non-IVD) RUOs

Hello,

I'm aware of the IVD guidance that exempts some IVDs from IDE requirements if they are RUO or IUO IVDs, and require labeling the IVDs as such (RUO or IOU). Medical devices can be investigational devices if they are not approved/cleared.

Can medical devices (non-IVD) be research use only devices? What is the criteria for that? Is there any guidance about that? I would presume that they cannot be used on patients unless part of an IDE or similar pathway as investigational devices.

Thanks
Hiral

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
------------------------------