Regulatory Open Forum

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

Hi Julie,
The manufacturer must not promote the off-label use of the device. You can look at adding this new indication for your device, but do not promote this until it's all cleared and approved.

Standard actions that you might take - depending on the off-label claim being made - can include: update your FAQs and make sure you clarify your patients or healthcare professionals that this in not an approved claim and your TF does not support this therefore you, as manufacturer,  cannot support this use - make sure your medical information and costumer services are trained and aware of this in order to properly reply in case you get calls on this. Also, make sure you train your sales team in case this comes up during visits to Healthcare professionals. You can also send letters to Healthcare professionals or Healthcare services. If needed you can also update your labelling to clearly identify what's within the approved intent use and what's not - this can be good if you're getting a lot of calls or getting contacted a lot on this.
Hope this helps

Ana    

------------------------------
Ana Cruz
Johnson & Johnson Medical Ltd
United Kingdom
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

I agree the manufacturer's regulatory responsibility revolves around the use for which it markets the device, not how people might actually use it, for better or for worse.  Manufacturers are responsible for providing complete and accurate labeling and instructions for use, but only for the use(s) for which they market the device.

From a regulatory perspective, the long-standing wisdom was that manufacturers should give off-label use a wide birth, for fear of saying or doing something that FDA might consider "promoting" the off-label use.  In recent years, FDA has softened its position a teensy bit, so that now many manufacturers seem comfortable providing data and information related to off-label use in response to a direct inquiry from a physician, but only hard information, no opinions.



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Feb-2017 06:15
From: Ana Cruz
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Hi Julie,
The manufacturer must not promote the off-label use of the device. You can look at adding this new indication for your device, but do not promote this until it's all cleared and approved.

Standard actions that you might take - depending on the off-label claim being made - can include: update your FAQs and make sure you clarify your patients or healthcare professionals that this in not an approved claim and your TF does not support this therefore you, as manufacturer,  cannot support this use - make sure your medical information and costumer services are trained and aware of this in order to properly reply in case you get calls on this. Also, make sure you train your sales team in case this comes up during visits to Healthcare professionals. You can also send letters to Healthcare professionals or Healthcare services. If needed you can also update your labelling to clearly identify what's within the approved intent use and what's not - this can be good if you're getting a lot of calls or getting contacted a lot on this.
Hope this helps

Ana    

------------------------------
Ana Cruz
Johnson & Johnson Medical Ltd
United Kingdom
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

Julie -

As you know, "required" is such a strong word in our line of work...

Of course, depending on the severity of the issue, the manufacturer's own quality system/risk management requirements and local regulations, there are various considerations. For example, it may be appropriate to update warnings, precautions or contraindications. Direct communication to customers may also be appropriate.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

I looked for an example to show what I am inquiring about.  Here is a specific, simple example of the type of thing I wonder about.

Blood-pressure measurement device (sphygmomanometer).  Recent cleared Indication for Use is the following:
The <device name> sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure.

Over time, clinicians have found DIAGNOSTIC uses for the device not included in the cleared Indication for Use.  I have found, for example, techniques for diagnosis of orthostatic hypotension that use the sphygmomanometer:  "Blood pressure monitoring. Your doctor will measure your blood pressure both while you're sitting and while you're standing and will compare the measurements. Your doctor will diagnose orthostatic hypotension if you have a drop of 20 millimeters of mercury (mm Hg) in your systolic blood pressure or a drop of 10 mm Hg in your diastolic blood pressure within two to five minutes of standing up, or if standing causes signs and symptoms." http://www.mayoclinic.org/diseases-conditions/orthostatic-hypotension/basics/tests-diagnosis/con-20031255

Also, I found this one about measuring blood pressure in each arm and comparing the results obtained as a diagnosis/indicator of peripheral artery disease.: "People with an arm-to-arm difference of 15 points or more were twice as likely to have peripheral artery disease."  http://www.health.harvard.edu/blog/different-blood-pressure-in-right-and-left-arms-could-signal-trouble-201202014174. 

So, in there cases, the practice of medicine has determined new uses for the device beyond those claimed.  What is the manufacturer's responsibility?  Must each be evaluated for risk?  Must each new indication be submitted for clearance/approval?  May references for these peer-reviewed applications be used in marketing materials?

Thank you for any further thoughts.

Kind regards,
Debbie

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

Original Message:
Sent: 08-Feb-2017 14:18
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Julie -

As you know, "required" is such a strong word in our line of work...

Of course, depending on the severity of the issue, the manufacturer's own quality system/risk management requirements and local regulations, there are various considerations. For example, it may be appropriate to update warnings, precautions or contraindications. Direct communication to customers may also be appropriate.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

IMO:  None, no, no, and no.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Feb-2017 17:40
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

I looked for an example to show what I am inquiring about.  Here is a specific, simple example of the type of thing I wonder about.

Blood-pressure measurement device (sphygmomanometer).  Recent cleared Indication for Use is the following:
The <device name> sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure.

Over time, clinicians have found DIAGNOSTIC uses for the device not included in the cleared Indication for Use.  I have found, for example, techniques for diagnosis of orthostatic hypotension that use the sphygmomanometer:  "Blood pressure monitoring. Your doctor will measure your blood pressure both while you're sitting and while you're standing and will compare the measurements. Your doctor will diagnose orthostatic hypotension if you have a drop of 20 millimeters of mercury (mm Hg) in your systolic blood pressure or a drop of 10 mm Hg in your diastolic blood pressure within two to five minutes of standing up, or if standing causes signs and symptoms." http://www.mayoclinic.org/diseases-conditions/orthostatic-hypotension/basics/tests-diagnosis/con-20031255

Also, I found this one about measuring blood pressure in each arm and comparing the results obtained as a diagnosis/indicator of peripheral artery disease.: "People with an arm-to-arm difference of 15 points or more were twice as likely to have peripheral artery disease."  http://www.health.harvard.edu/blog/different-blood-pressure-in-right-and-left-arms-could-signal-trouble-201202014174. 

So, in there cases, the practice of medicine has determined new uses for the device beyond those claimed.  What is the manufacturer's responsibility?  Must each be evaluated for risk?  Must each new indication be submitted for clearance/approval?  May references for these peer-reviewed applications be used in marketing materials?

Thank you for any further thoughts.

Kind regards,
Debbie

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

Original Message:
Sent: 08-Feb-2017 14:18
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Julie -

As you know, "required" is such a strong word in our line of work...

Of course, depending on the severity of the issue, the manufacturer's own quality system/risk management requirements and local regulations, there are various considerations. For example, it may be appropriate to update warnings, precautions or contraindications. Direct communication to customers may also be appropriate.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

I agree, but I think it's helpful to clarify whether you are talking about what's "required" by FDA versus what is wise from a regulatory, business, and/or legal perspective.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Feb-2017 14:18
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Julie -

As you know, "required" is such a strong word in our line of work...

Of course, depending on the severity of the issue, the manufacturer's own quality system/risk management requirements and local regulations, there are various considerations. For example, it may be appropriate to update warnings, precautions or contraindications. Direct communication to customers may also be appropriate.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

I guess I should add "....or by other regulatory agencies."  I don't think FDA wants manufacturers to get at all involved in off-label use.  Other agencies may think differently.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 09-Feb-2017 13:11
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

I agree, but I think it's helpful to clarify whether you are talking about what's "required" by FDA versus what is wise from a regulatory, business, and/or legal perspective.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Feb-2017 14:18
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Julie -

As you know, "required" is such a strong word in our line of work...

Of course, depending on the severity of the issue, the manufacturer's own quality system/risk management requirements and local regulations, there are various considerations. For example, it may be appropriate to update warnings, precautions or contraindications. Direct communication to customers may also be appropriate.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

with regards to the 4 questions placed by Debra:
"So, in there cases, the practice of medicine has determined new uses for the device beyond those claimed.  What is the manufacturer's responsibility?"
None.

"Must each be evaluated for risk?"
Once the new, off-label use is published, it becomes a known misuse. Common sense suggests that a known misuse should be processed by the manufacturer with the same attention of a reasonably foreseeable misuse. Considering that one of the basic requirements of usability is to carry out the risk analysis for reasonably foreseeable misuse, I would answer YES.

"Must each new indication be submitted for clearance/approval?"
No

"May references for these peer-reviewed applications be used in marketing materials?""
No

Kind Regards

------------------------------
Lorenzo Muratori
Elekta
West Sussex
United Kingdom
------------------------------

Original Message:
Sent: 09-Feb-2017 13:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

I guess I should add "....or by other regulatory agencies."  I don't think FDA wants manufacturers to get at all involved in off-label use.  Other agencies may think differently.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 09-Feb-2017 13:11
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

I agree, but I think it's helpful to clarify whether you are talking about what's "required" by FDA versus what is wise from a regulatory, business, and/or legal perspective.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Feb-2017 14:18
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Julie -

As you know, "required" is such a strong word in our line of work...

Of course, depending on the severity of the issue, the manufacturer's own quality system/risk management requirements and local regulations, there are various considerations. For example, it may be appropriate to update warnings, precautions or contraindications. Direct communication to customers may also be appropriate.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

Lorenzo, that sounds good, too.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 13-Feb-2017 11:26
From: Lorenzo Muratori
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

with regards to the 4 questions placed by Debra:
"So, in there cases, the practice of medicine has determined new uses for the device beyond those claimed.  What is the manufacturer's responsibility?"
None.

"Must each be evaluated for risk?"
Once the new, off-label use is published, it becomes a known misuse. Common sense suggests that a known misuse should be processed by the manufacturer with the same attention of a reasonably foreseeable misuse. Considering that one of the basic requirements of usability is to carry out the risk analysis for reasonably foreseeable misuse, I would answer YES.

"Must each new indication be submitted for clearance/approval?"
No

"May references for these peer-reviewed applications be used in marketing materials?""
No

Kind Regards

------------------------------
Lorenzo Muratori
Elekta
West Sussex
United Kingdom
------------------------------

Original Message:
Sent: 09-Feb-2017 13:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

I guess I should add "....or by other regulatory agencies."  I don't think FDA wants manufacturers to get at all involved in off-label use.  Other agencies may think differently.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 09-Feb-2017 13:11
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

I agree, but I think it's helpful to clarify whether you are talking about what's "required" by FDA versus what is wise from a regulatory, business, and/or legal perspective.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Feb-2017 14:18
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Julie -

As you know, "required" is such a strong word in our line of work...

Of course, depending on the severity of the issue, the manufacturer's own quality system/risk management requirements and local regulations, there are various considerations. For example, it may be appropriate to update warnings, precautions or contraindications. Direct communication to customers may also be appropriate.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

I have another similar senario:  This device is cleared via a tradtional 510(k) earlier with an indication “The <cleared device> is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The <cleared device> is indicated for use with a compatible Camera Head and other accessory devices including an endoscope, optical coupler, and light cable.”

For the purpose of this discussion, in this scenario, could a manufacturer promote this device as “This device is intended to use to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”?

------------------------------
Lin Wu RAC
Waltham MA
United States
------------------------------

Original Message:
Sent: 13-Feb-2017 21:34
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Lorenzo, that sounds good, too.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 13-Feb-2017 11:26
From: Lorenzo Muratori
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

with regards to the 4 questions placed by Debra:
"So, in there cases, the practice of medicine has determined new uses for the device beyond those claimed.  What is the manufacturer's responsibility?"
None.

"Must each be evaluated for risk?"
Once the new, off-label use is published, it becomes a known misuse. Common sense suggests that a known misuse should be processed by the manufacturer with the same attention of a reasonably foreseeable misuse. Considering that one of the basic requirements of usability is to carry out the risk analysis for reasonably foreseeable misuse, I would answer YES.

"Must each new indication be submitted for clearance/approval?"
No

"May references for these peer-reviewed applications be used in marketing materials?""
No

Kind Regards

------------------------------
Lorenzo Muratori
Elekta
West Sussex
United Kingdom
------------------------------

Original Message:
Sent: 09-Feb-2017 13:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

I guess I should add "....or by other regulatory agencies."  I don't think FDA wants manufacturers to get at all involved in off-label use.  Other agencies may think differently.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 09-Feb-2017 13:11
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

I agree, but I think it's helpful to clarify whether you are talking about what's "required" by FDA versus what is wise from a regulatory, business, and/or legal perspective.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Feb-2017 14:18
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Julie -

As you know, "required" is such a strong word in our line of work...

Of course, depending on the severity of the issue, the manufacturer's own quality system/risk management requirements and local regulations, there are various considerations. For example, it may be appropriate to update warnings, precautions or contraindications. Direct communication to customers may also be appropriate.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------

In Debra's senario, I would agree with Lorenzo's comments.

------------------------------
Lin Wu RAC
Waltham MA
United States
------------------------------

Original Message:
Sent: 13-Feb-2017 11:26
From: Lorenzo Muratori
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

with regards to the 4 questions placed by Debra:
"So, in there cases, the practice of medicine has determined new uses for the device beyond those claimed.  What is the manufacturer's responsibility?"
None.

"Must each be evaluated for risk?"
Once the new, off-label use is published, it becomes a known misuse. Common sense suggests that a known misuse should be processed by the manufacturer with the same attention of a reasonably foreseeable misuse. Considering that one of the basic requirements of usability is to carry out the risk analysis for reasonably foreseeable misuse, I would answer YES.

"Must each new indication be submitted for clearance/approval?"
No

"May references for these peer-reviewed applications be used in marketing materials?""
No

Kind Regards

------------------------------
Lorenzo Muratori
Elekta
West Sussex
United Kingdom
------------------------------

Original Message:
Sent: 09-Feb-2017 13:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

I guess I should add "....or by other regulatory agencies."  I don't think FDA wants manufacturers to get at all involved in off-label use.  Other agencies may think differently.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 09-Feb-2017 13:11
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

I agree, but I think it's helpful to clarify whether you are talking about what's "required" by FDA versus what is wise from a regulatory, business, and/or legal perspective.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Feb-2017 14:18
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Julie -

As you know, "required" is such a strong word in our line of work...

Of course, depending on the severity of the issue, the manufacturer's own quality system/risk management requirements and local regulations, there are various considerations. For example, it may be appropriate to update warnings, precautions or contraindications. Direct communication to customers may also be appropriate.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 21:40
From: Julie Omohundro
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Paul, can you give some examples of actions the manufacturer might be required to take?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-Feb-2017 15:06
From: Paul Swift
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

Debra -

Your post hits on a couple of points, both of which are relatively common: 1) general to specific intended use; 2) off-label usage via the practice of medicine. Without going into too much depth here, the most important responsibility on the manufacturer's side relates to patient and customer safety. If a manufacturer has knowledge or reason to believe that patients or customers may be (or have been) harmed by uses in the field, they have a responsibility to take action. The specific action may vary, of course, and scale in accordance with the risks presented.

------------------------------
Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
------------------------------

Original Message:
Sent: 07-Feb-2017 14:47
From: Debra Hutson
Subject: Indication for use/Intended use Changes by USERS. Mfr responsibility?

A medical device is 'cleared' or 'approved' with a specific Indications for Use statement that is issued with the clearance letter.  If not 510(K), the device carries the use described in its regulation or further defined with the product code.  Manufacturers are supposed to only market to that Indication for Use or device definition.

In the field, however, users may discover ANOTHER use for the device or a more focused use and may prove its appropriateness and publish the application in peer-reviewed scholarly publications.  They may even start to train other users in this new use.  So, now a legitimately 'proven' new application has been presented to the 'practice of medicine.' 

What it the responsibility, if any, of the manufacturer about this 'off-label' or extended application use?

Is anyone aware of any cases like this where an original (maybe really old) intended use for a device has morphed into a new practice, generally accepted in the field?

Thank you for your thoughts!

------------------------------
Debra Hutson
Maurer & Hutson Consulting
Snohomish WA
United States
------------------------------