Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Good afternoon Regulatory folks!, 

I was working on medical device labeling for a device that is to be used in hospitals and clinics. This device is packaged in a crate and I was wondering, would this device need to have Rx Symbol on it's label/Package Label/ IFU?

your insight is highly appreciated. 

Thanks, 
Vinoda

This might be a tricky question, or might be an easy one.  Let's start with one of the easiest ways to know whether a medical device's U.S. label needs to contain the Rx Only symbol (or the longer narrative analog).

For example, if the subject device is 510(k)-cleared, then look at the FDA clearance documentation.  Specifically, if FDA has marked, or concurred with the marking of, the prescription use box on the Indications for Use page, then the device's label is required to have the Rx Only (or the longer narrative analog).

In a more general sense for any medical device for U.S. use, this requirement applies to any device that is only for use by, or under the supervision of, a licensed healthcare practitioner.

Note that this requirement isn't generally affected by the type of packaging.  The device label still must conform with this requirement even if the device is packaged in a crate.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 04-Oct-2022 16:59
From: Anonymous Member
Subject: FDA labeling - Rx Symbol

This message was posted by a user wishing to remain anonymous

Good afternoon Regulatory folks!,

I was working on medical device labeling for a device that is to be used in hospitals and clinics. This device is packaged in a crate and I was wondering, would this device need to have Rx Symbol on it's label/Package Label/ IFU?

your insight is highly appreciated.

Thanks,
Vinoda

Thanks Kevin. This is very helpful. 

Thanks, 
Vinoda

------------------------------
Vinoda Palanisamy
Princeton NJ
United States
------------------------------

Original Message:
Sent: 05-Oct-2022 10:12
From: Kevin Randall
Subject: FDA labeling - Rx Symbol

This might be a tricky question, or might be an easy one.  Let's start with one of the easiest ways to know whether a medical device's U.S. label needs to contain the Rx Only symbol (or the longer narrative analog).

For example, if the subject device is 510(k)-cleared, then look at the FDA clearance documentation.  Specifically, if FDA has marked, or concurred with the marking of, the prescription use box on the Indications for Use page, then the device's label is required to have the Rx Only (or the longer narrative analog).

In a more general sense for any medical device for U.S. use, this requirement applies to any device that is only for use by, or under the supervision of, a licensed healthcare practitioner.

Note that this requirement isn't generally affected by the type of packaging.  The device label still must conform with this requirement even if the device is packaged in a crate.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Oct-2022 16:59
From: Anonymous Member
Subject: FDA labeling - Rx Symbol

This message was posted by a user wishing to remain anonymous

Good afternoon Regulatory folks!,

I was working on medical device labeling for a device that is to be used in hospitals and clinics. This device is packaged in a crate and I was wondering, would this device need to have Rx Symbol on it's label/Package Label/ IFU?

your insight is highly appreciated.

Thanks,
Vinoda

This message was posted by a user wishing to remain anonymous

Thank you. Are there pros and cons to putting the symbol when it is not strictly required?
Original Message:
Sent: 05-Oct-2022 10:12
From: Kevin Randall
Subject: FDA labeling - Rx Symbol

This might be a tricky question, or might be an easy one.  Let's start with one of the easiest ways to know whether a medical device's U.S. label needs to contain the Rx Only symbol (or the longer narrative analog).

For example, if the subject device is 510(k)-cleared, then look at the FDA clearance documentation.  Specifically, if FDA has marked, or concurred with the marking of, the prescription use box on the Indications for Use page, then the device's label is required to have the Rx Only (or the longer narrative analog).

In a more general sense for any medical device for U.S. use, this requirement applies to any device that is only for use by, or under the supervision of, a licensed healthcare practitioner.

Note that this requirement isn't generally affected by the type of packaging.  The device label still must conform with this requirement even if the device is packaged in a crate.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Oct-2022 16:59
From: Anonymous Member
Subject: FDA labeling - Rx Symbol

This message was posted by a user wishing to remain anonymous

Good afternoon Regulatory folks!,

I was working on medical device labeling for a device that is to be used in hospitals and clinics. This device is packaged in a crate and I was wondering, would this device need to have Rx Symbol on it's label/Package Label/ IFU?

your insight is highly appreciated.

Thanks,
Vinoda

Remember that in the U.S., if the device is for prescription use only, then the symbol (or narrative analog) is a regulatory requirement.  Failure to have it when required will result in the device being misbranded (i.e., not legally labeled).

Another thing that can cause a device to be misbranded in the U.S. is if the label is not truthful, not accurate, or is otherwise misleading (my paraphrased language).  Accordingly, if the labeler puts on the Rx Only symbol when the device actually isn't a prescription use device, then that could represent a violative label from a compliance standpoint.  This same type of accuracy principle also applies in jurisdictions outside the U.S.

I'm sure others in the Forum also have thoughts on this topic.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 05-Oct-2022 10:39
From: Anonymous Member
Subject: FDA labeling - Rx Symbol

This message was posted by a user wishing to remain anonymous

Thank you. Are there pros and cons to putting the symbol when it is not strictly required?
Original Message:
Sent: 05-Oct-2022 10:12
From: Kevin Randall
Subject: FDA labeling - Rx Symbol

This might be a tricky question, or might be an easy one.  Let's start with one of the easiest ways to know whether a medical device's U.S. label needs to contain the Rx Only symbol (or the longer narrative analog).

For example, if the subject device is 510(k)-cleared, then look at the FDA clearance documentation.  Specifically, if FDA has marked, or concurred with the marking of, the prescription use box on the Indications for Use page, then the device's label is required to have the Rx Only (or the longer narrative analog).

In a more general sense for any medical device for U.S. use, this requirement applies to any device that is only for use by, or under the supervision of, a licensed healthcare practitioner.

Note that this requirement isn't generally affected by the type of packaging.  The device label still must conform with this requirement even if the device is packaged in a crate.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Oct-2022 16:59
From: Anonymous Member
Subject: FDA labeling - Rx Symbol

This message was posted by a user wishing to remain anonymous

Good afternoon Regulatory folks!,

I was working on medical device labeling for a device that is to be used in hospitals and clinics. This device is packaged in a crate and I was wondering, would this device need to have Rx Symbol on it's label/Package Label/ IFU?

your insight is highly appreciated.

Thanks,
Vinoda

Hi Anonymous.

Completely agree with Kevin.  In fact, that was my first thought when I read your follow request for information about pros and cons.  Remember - in the US the rule is that if the label is false or misleading in any particular then the label is considered violative of the regulations.  So if the product is not Rx only and you put the Rx symbol or statement on the label, you are both false (saying a prescription is required when it is not) and misleading (inaccurately implying that a helathcare practitioner is required to safely use the device) and therefore you are likely to get a call or mail note from your friendly neighborhood office or from Washington (if you are a non-US firm) to fix it.

------------------------------
Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
------------------------------

Original Message:
Sent: 05-Oct-2022 18:29
From: Kevin Randall
Subject: FDA labeling - Rx Symbol

Remember that in the U.S., if the device is for prescription use only, then the symbol (or narrative analog) is a regulatory requirement.  Failure to have it when required will result in the device being misbranded (i.e., not legally labeled).

Another thing that can cause a device to be misbranded in the U.S. is if the label is not truthful, not accurate, or is otherwise misleading (my paraphrased language).  Accordingly, if the labeler puts on the Rx Only symbol when the device actually isn't a prescription use device, then that could represent a violative label from a compliance standpoint.  This same type of accuracy principle also applies in jurisdictions outside the U.S.

I'm sure others in the Forum also have thoughts on this topic.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 05-Oct-2022 10:39
From: Anonymous Member
Subject: FDA labeling - Rx Symbol

This message was posted by a user wishing to remain anonymous

Thank you. Are there pros and cons to putting the symbol when it is not strictly required?
Original Message:
Sent: 05-Oct-2022 10:12
From: Kevin Randall
Subject: FDA labeling - Rx Symbol

This might be a tricky question, or might be an easy one.  Let's start with one of the easiest ways to know whether a medical device's U.S. label needs to contain the Rx Only symbol (or the longer narrative analog).

For example, if the subject device is 510(k)-cleared, then look at the FDA clearance documentation.  Specifically, if FDA has marked, or concurred with the marking of, the prescription use box on the Indications for Use page, then the device's label is required to have the Rx Only (or the longer narrative analog).

In a more general sense for any medical device for U.S. use, this requirement applies to any device that is only for use by, or under the supervision of, a licensed healthcare practitioner.

Note that this requirement isn't generally affected by the type of packaging.  The device label still must conform with this requirement even if the device is packaged in a crate.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Oct-2022 16:59
From: Anonymous Member
Subject: FDA labeling - Rx Symbol

This message was posted by a user wishing to remain anonymous

Good afternoon Regulatory folks!,

I was working on medical device labeling for a device that is to be used in hospitals and clinics. This device is packaged in a crate and I was wondering, would this device need to have Rx Symbol on it's label/Package Label/ IFU?

your insight is highly appreciated.

Thanks,
Vinoda

Thanks for the insight everyone.

------------------------------
Divakar Raj Dinakaran
Chennai
India
------------------------------

Original Message:
Sent: 06-Oct-2022 09:18
From: Victor Mencarelli
Subject: FDA labeling - Rx Symbol

Hi Anonymous.

Completely agree with Kevin.  In fact, that was my first thought when I read your follow request for information about pros and cons.  Remember - in the US the rule is that if the label is false or misleading in any particular then the label is considered violative of the regulations.  So if the product is not Rx only and you put the Rx symbol or statement on the label, you are both false (saying a prescription is required when it is not) and misleading (inaccurately implying that a helathcare practitioner is required to safely use the device) and therefore you are likely to get a call or mail note from your friendly neighborhood office or from Washington (if you are a non-US firm) to fix it.

------------------------------
Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States

Original Message:
Sent: 05-Oct-2022 18:29
From: Kevin Randall
Subject: FDA labeling - Rx Symbol

Remember that in the U.S., if the device is for prescription use only, then the symbol (or narrative analog) is a regulatory requirement.  Failure to have it when required will result in the device being misbranded (i.e., not legally labeled).

Another thing that can cause a device to be misbranded in the U.S. is if the label is not truthful, not accurate, or is otherwise misleading (my paraphrased language).  Accordingly, if the labeler puts on the Rx Only symbol when the device actually isn't a prescription use device, then that could represent a violative label from a compliance standpoint.  This same type of accuracy principle also applies in jurisdictions outside the U.S.

I'm sure others in the Forum also have thoughts on this topic.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 05-Oct-2022 10:39
From: Anonymous Member
Subject: FDA labeling - Rx Symbol

This message was posted by a user wishing to remain anonymous

Thank you. Are there pros and cons to putting the symbol when it is not strictly required?
Original Message:
Sent: 05-Oct-2022 10:12
From: Kevin Randall
Subject: FDA labeling - Rx Symbol

This might be a tricky question, or might be an easy one.  Let's start with one of the easiest ways to know whether a medical device's U.S. label needs to contain the Rx Only symbol (or the longer narrative analog).

For example, if the subject device is 510(k)-cleared, then look at the FDA clearance documentation.  Specifically, if FDA has marked, or concurred with the marking of, the prescription use box on the Indications for Use page, then the device's label is required to have the Rx Only (or the longer narrative analog).

In a more general sense for any medical device for U.S. use, this requirement applies to any device that is only for use by, or under the supervision of, a licensed healthcare practitioner.

Note that this requirement isn't generally affected by the type of packaging.  The device label still must conform with this requirement even if the device is packaged in a crate.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Oct-2022 16:59
From: Anonymous Member
Subject: FDA labeling - Rx Symbol

This message was posted by a user wishing to remain anonymous

Good afternoon Regulatory folks!,

I was working on medical device labeling for a device that is to be used in hospitals and clinics. This device is packaged in a crate and I was wondering, would this device need to have Rx Symbol on it's label/Package Label/ IFU?

your insight is highly appreciated.

Thanks,
Vinoda