Regulatory Open Forum

​​Hi All,

This is for a Medical Device System which is a prescription device.

As per 21 CFR 801.109 (Prescription Devices) - the label of the device should bear:

The symbol statement "Rx only" or "℞ only" or the statement "Caution: Federal law restricts this device to sale by or on the order of a ___", the blank to be filled with the word "physician", "dentist", "veterinarian", or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device;

Is it ok for the "Rx only" symbol to be only on the main system label OR should the "Rx only" symbol must appear on the labels of all the parts of the system?

Any guidance will be highly appreciated!

Thanks,

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Meenakshi,

From my experience and opinion the Rx symbol at a minimum needs to be on the main system label; this is the typical label on the back of the instrument with the model number, serial number, etc.  Regarding if symbol should be on any of the part labels should be assessed from a risk perspective and user perspective.  The regulation is not specific enough stating requirements for each instance that an Rx symbol (or even other regulatory information) should be on each product label.  As you can imagine, there are so many different medical devices it would be difficult for a regulation to be written to cover all instances.  So an approach of risk and user perspective should be documented internally by your company why or why not a Rx symbol would be on labelling.  Make sure this rationale is documented clearly.  As an example, if you have a part of the main system that can be sold separately, opened separately, etc., then it might make sense to have an Rx symbol on the part as it is "separate" from the main system needing to be made clear that the part of the system is also prescription and associated with the main system.

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

Original Message:
Sent: 10-Jan-2019 13:09
From: Meenakshi Verma
Subject: 510k - Prescription devices

​​Hi All,

This is for a Medical Device System which is a prescription device.

As per 21 CFR 801.109 (Prescription Devices) - the label of the device should bear:

The symbol statement "Rx only" or "℞ only" or the statement "Caution: Federal law restricts this device to sale by or on the order of a ___", the blank to be filled with the word "physician", "dentist", "veterinarian", or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device;

Is it ok for the "Rx only" symbol to be only on the main system label OR should the "Rx only" symbol must appear on the labels of all the parts of the system?

Any guidance will be highly appreciated!

Thanks,

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Thanks Richard!
This is helpful!

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Original Message:
Sent: 11-Jan-2019 08:51
From: Richard Vincins
Subject: 510k - Prescription devices

Meenakshi,

From my experience and opinion the Rx symbol at a minimum needs to be on the main system label; this is the typical label on the back of the instrument with the model number, serial number, etc.  Regarding if symbol should be on any of the part labels should be assessed from a risk perspective and user perspective.  The regulation is not specific enough stating requirements for each instance that an Rx symbol (or even other regulatory information) should be on each product label.  As you can imagine, there are so many different medical devices it would be difficult for a regulation to be written to cover all instances.  So an approach of risk and user perspective should be documented internally by your company why or why not a Rx symbol would be on labelling.  Make sure this rationale is documented clearly.  As an example, if you have a part of the main system that can be sold separately, opened separately, etc., then it might make sense to have an Rx symbol on the part as it is "separate" from the main system needing to be made clear that the part of the system is also prescription and associated with the main system.

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

Original Message:
Sent: 10-Jan-2019 13:09
From: Meenakshi Verma
Subject: 510k - Prescription devices

​​Hi All,

This is for a Medical Device System which is a prescription device.

As per 21 CFR 801.109 (Prescription Devices) - the label of the device should bear:

The symbol statement "Rx only" or "℞ only" or the statement "Caution: Federal law restricts this device to sale by or on the order of a ___", the blank to be filled with the word "physician", "dentist", "veterinarian", or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device;

Is it ok for the "Rx only" symbol to be only on the main system label OR should the "Rx only" symbol must appear on the labels of all the parts of the system?

Any guidance will be highly appreciated!

Thanks,

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------