Regulatory Open Forum

Hi,

FDA has required us to add the Rx symbol on one of our IVD devices, for which we have submitted a 510(k). In my perception the Rx symbol only applies to prescription drugs and not to (prescription) IVD devices.

I have searched for any Rx labeling requirements on FDAs website and found 21CFR801.109, which covers Prescription Devices. But I can't find any Rx labeling requirements in this code. Apart from that, in this code prescription only aplies when use of a device "is not safe except under the supervision of a practitioner licensed by law to direct the use of such device". Our IVD device is to be used by laboratory professionals and point-of-care professionals.

I also found 21CFR201, which covers labeling requirements of drugs, incl. the Rx labeling requirement. But, as mentioned, our product is an IVD device and not a drug, so this code does not apply to our product.

Before I reply to FDA, and try to push back (...), I just wanted to check if anybody in this forum has any thoughts or even experiences on this issue. Any recommendation is welcomed!

Thanks. Paul

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Paul Kooijmans
Regulatory Affairs manager
The Netherlands
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Original Message------

Hi,

FDA has required us to add the Rx symbol on one of our IVD devices, for which we have submitted a 510(k). In my perception the Rx symbol only applies to prescription drugs and not to (prescription) IVD devices.

I have searched for any Rx labeling requirements on FDAs website and found 21CFR801.109, which covers Prescription Devices. But I can't find any Rx labeling requirements in this code. Apart from that, in this code prescription only aplies when use of a device "is not safe except under the supervision of a practitioner licensed by law to direct the use of such device". Our IVD device is to be used by laboratory professionals and point-of-care professionals.

I also found 21CFR201, which covers labeling requirements of drugs, incl. the Rx labeling requirement. But, as mentioned, our product is an IVD device and not a drug, so this code does not apply to our product.

Before I reply to FDA, and try to push back (...), I just wanted to check if anybody in this forum has any thoughts or even experiences on this issue. Any recommendation is welcomed!

Thanks. Paul

------------------------------
Paul Kooijmans
Regulatory Affairs manager
The Netherlands
------------------------------

Thanks a lot David! This is very helpful!

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Paul Kooijmans
Regulatory Affairs manager
Netherlands

Original Message:
Sent: 11-05-2015 07:18
From: David Lim
Subject: Rx labeling for IVD Medical Device

Paul,

Valid perception!

Per FDAMA, it was required for firms to use Rx for drugs.  

As for prescription devices, it wasn't required.  However, Rx is being used for prescription devices as an alternative to replace the language ""Caution: Federal law restricts this device to sale by or on the order of a ____"

Please refer to FDA guidance at http://fdaguidance.net/devicesivds/alternative-to-certain-prescription-device-labeling-requirements/

As for your IVD devices, use by "laboratory professionals and point-of-care professionals" should be interpreted as they are still under the descriptive designation (or guidance or direction) of "physician", "dentist", "veterinarian" or "any other practitioner".....

Thus, when/if you are asked to put Rx by the FDA reviewer(s), it might/would be a good choice to just put it unless it is unduly burdensome.

Thank you.  

s/ David

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 

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I would not push back on the "Rx Only".  I've had to put in "caution:..." so many times in so many languages years ago in medical devices I worked with that it made me very happy when FDA decided it is ok using "Rx Only" now.  Many medical device companies are using this on their product labeling instead of the longer "caution:..".  Just explain in the manual/instructions for use that "Rx Only" means "Caution:...".

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Clarisa Tate
Medical Device, RA & QA
Bay Area, CA
USA

Original Message:
Sent: 11-05-2015 11:10
From: Paul Kooijmans
Subject: Rx labeling for IVD Medical Device

Thanks a lot David! This is very helpful!

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Paul Kooijmans
Regulatory Affairs manager
Netherlands

Thank you for the advice, Clarissa! I'll take it in consideration.

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Paul Kooijmans
Regulatory Affairs manager
Netherlands

Original Message:
Sent: 11-05-2015 18:52
From: Clarisa Tate
Subject: Rx labeling for IVD Medical Device

I would not push back on the "Rx Only".  I've had to put in "caution:..." so many times in so many languages years ago in medical devices I worked with that it made me very happy when FDA decided it is ok using "Rx Only" now.  Many medical device companies are using this on their product labeling instead of the longer "caution:..".  Just explain in the manual/instructions for use that "Rx Only" means "Caution:...".

------------------------------
Clarisa Tate
Medical Device, RA & QA
Bay Area, CA
USA