Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks

​Greenlight Guru (who posts here) did a podcast on this topic:
The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

Duval Law (who also posts here) also had a good article related to this with reference to FDA's guidance on General / Specific Use and the 2014 new Substantial Equivalence guidance

http://www.duvalfdalaw.com/resources/documents/client-alerts/clearing-your-indications-for-use-staying-under-the-umbrella-of-intended-use-.pdf

Here's another article on it:
http://www.wmdo.org/article-detail.aspx?id=17

Original Message:
Sent: 02-Dec-2017 18:31
From: Anonymous Member
Subject: Intended use versus Indications for use

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks

Dear Samir,

Thank you for sharing. 

The first article link appears to be dead (Duval) and the second is redirected to the WMDO main page.

All the best.

------------------------------
Claus Rømer Andersen
Rømer Consulting Aps
Hørsholm, Denmark
claus@roemerconsulting.dk
------------------------------

Original Message:
Sent: 04-Dec-2017 09:40
From: Samir Shah
Subject: Intended use versus Indications for use

​Greenlight Guru (who posts here) did a podcast on this topic:
The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

Duval Law (who also posts here) also had a good article related to this with reference to FDA's guidance on General / Specific Use and the 2014 new Substantial Equivalence guidance

http://www.duvalfdalaw.com/resources/documents/client-alerts/clearing-your-indications-for-use-staying-under-the-umbrella-of-intended-use-.pdf

Here's another article on it:
http://www.wmdo.org/article-detail.aspx?id=17

Original Message:
Sent: 02-Dec-2017 18:31
From: Anonymous Member
Subject: Intended use versus Indications for use

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks

​​Hi Claus,

Here's another link that might be of interest: Medtec China: Why You Must Know the Difference Between 'Intended Use' and 'Indications for Use'.

Best,
Liz

------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Project Manager
United States
------------------------------

Original Message:
Sent: 04-Dec-2017 10:59
From: Claus Andersen
Subject: Intended use versus Indications for use

Dear Samir,

Thank you for sharing.

The first article link appears to be dead (Duval) and the second is redirected to the WMDO main page.

All the best.

------------------------------
Claus Rømer Andersen
Rømer Consulting Aps
Hørsholm, Denmark
claus@roemerconsulting.dk

Original Message:
Sent: 04-Dec-2017 09:40
From: Samir Shah
Subject: Intended use versus Indications for use

​Greenlight Guru (who posts here) did a podcast on this topic:
The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

Duval Law (who also posts here) also had a good article related to this with reference to FDA's guidance on General / Specific Use and the 2014 new Substantial Equivalence guidance

http://www.duvalfdalaw.com/resources/documents/client-alerts/clearing-your-indications-for-use-staying-under-the-umbrella-of-intended-use-.pdf

Here's another article on it:
http://www.wmdo.org/article-detail.aspx?id=17

Original Message:
Sent: 02-Dec-2017 18:31
From: Anonymous Member
Subject: Intended use versus Indications for use

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks

​Sorry about that. I clip these articles into my Evernote and so I have the URL from the time I clipped them. I searched and found those two articles here: 

http://www.duvalfdalaw.com/documents/client-alerts/clearing-your-indications-for-use-staying-under-the-umbrella-of-intended-use-.pdf
http://www.rqmis.com/blog/entry/a-need-to-define-and-correctly-apply-this-terminology-in-the-regulatory-review-process

Original Message:
Sent: 04-Dec-2017 10:59
From: Claus Andersen
Subject: Intended use versus Indications for use

Dear Samir,

Thank you for sharing.

The first article link appears to be dead (Duval) and the second is redirected to the WMDO main page.

All the best.

------------------------------
Claus Rømer Andersen
Rømer Consulting Aps
Hørsholm, Denmark
claus@roemerconsulting.dk

Original Message:
Sent: 04-Dec-2017 09:40
From: Samir Shah
Subject: Intended use versus Indications for use

​Greenlight Guru (who posts here) did a podcast on this topic:
The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

Duval Law (who also posts here) also had a good article related to this with reference to FDA's guidance on General / Specific Use and the 2014 new Substantial Equivalence guidance

http://www.duvalfdalaw.com/resources/documents/client-alerts/clearing-your-indications-for-use-staying-under-the-umbrella-of-intended-use-.pdf

Here's another article on it:
http://www.wmdo.org/article-detail.aspx?id=17

Original Message:
Sent: 02-Dec-2017 18:31
From: Anonymous Member
Subject: Intended use versus Indications for use

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks

This message was posted by a user wishing to remain anonymous

​Thanks, Samir the podcast was very helpful. Thanks to all members for their reply and helping me understand this.
Original Message:
Sent: 05-Dec-2017 11:43
From: Samir Shah
Subject: Intended use versus Indications for use

​Sorry about that. I clip these articles into my Evernote and so I have the URL from the time I clipped them. I searched and found those two articles here:

http://www.duvalfdalaw.com/documents/client-alerts/clearing-your-indications-for-use-staying-under-the-umbrella-of-intended-use-.pdf
http://www.rqmis.com/blog/entry/a-need-to-define-and-correctly-apply-this-terminology-in-the-regulatory-review-process

Original Message:
Sent: 04-Dec-2017 10:59
From: Claus Andersen
Subject: Intended use versus Indications for use

Dear Samir,

Thank you for sharing.

The first article link appears to be dead (Duval) and the second is redirected to the WMDO main page.

All the best.

------------------------------
Claus Rømer Andersen
Rømer Consulting Aps
Hørsholm, Denmark
claus@roemerconsulting.dk

Original Message:
Sent: 04-Dec-2017 09:40
From: Samir Shah
Subject: Intended use versus Indications for use

​Greenlight Guru (who posts here) did a podcast on this topic:
The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

Duval Law (who also posts here) also had a good article related to this with reference to FDA's guidance on General / Specific Use and the 2014 new Substantial Equivalence guidance

http://www.duvalfdalaw.com/resources/documents/client-alerts/clearing-your-indications-for-use-staying-under-the-umbrella-of-intended-use-.pdf

Here's another article on it:
http://www.wmdo.org/article-detail.aspx?id=17

Original Message:
Sent: 02-Dec-2017 18:31
From: Anonymous Member
Subject: Intended use versus Indications for use

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks

Original Message------

This message was posted by a user wishing to remain anonymous

​Thanks, Samir the podcast was very helpful. Thanks to all members for their reply and helping me understand this.

Hi,

FDA's definition of Intended use: "Intended use is the objective intent of the persons legally responsible for the labeling of drugs. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article."

 

Indication for use: general description of the disease or condition the drug will diagnose, treat, prevent, cure or mitigate including a description of the patient population for which the device is intended.

Hope this helps!

------------------------------
Nitisha Pyndiah PhD
Consultant
Hartmannwillner
Washington DC
United States
------------------------------

Original Message:
Sent: 02-Dec-2017 18:31
From: Anonymous Member
Subject: Intended use versus Indications for use

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks

If I could provide some comments, there is an FDA guidance that talks a bit about intended use and indications for use, but there is not really any specific definition for these two terms.  However, as was explained to me by a couple FDA reviewers over the years the basic concept is the following.

Intended Use: This is a general statement about what the device does.  As an example:  Implant device used for long bones.

Indications for Use: This is a more specific statement concerning population, anatomy, situation, or conditions of use.  An an example: A titanium plate device that is used for long bone securement in the lower limbs (legs) to provide structural support in adult patients.

This is just a rough example, but indications for use is more specific.  In my own experience, the FDA does not work with intended use, they only work with indications for use.  However, other regulatory agencies use intended use which is usually accepted.  Though over time more regulatory agencies are using indications for use statements, and not using intended use.

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

Original Message:
Sent: 02-Dec-2017 18:31
From: Anonymous Member
Subject: Intended use versus Indications for use

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks

Not necessarily. For general use devices, it is common for the Indications for Use to have a long list of general things for which the device has "Indications". Look up Surgical lasers as an example. There are a lot of nuances of "general to specific" but suffice it to say, very often specific lasers are focused in a certain area (say Urology/BPH or Kidney stones). These lasers will have "intended use" for the more specific areas, which generally allows the IFU to be specific to the use in urology (even if the Indications cover dermatology and other things).

One of the bigger challenges with device regulations is the large variation of devices and thus sometimes Intended Use if more specific and sometimes it is less specific.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 05-Dec-2017 14:59
From: Richard Vincins
Subject: Intended use versus Indications for use

If I could provide some comments, there is an FDA guidance that talks a bit about intended use and indications for use, but there is not really any specific definition for these two terms.  However, as was explained to me by a couple FDA reviewers over the years the basic concept is the following.

Intended Use: This is a general statement about what the device does.  As an example:  Implant device used for long bones.

Indications for Use: This is a more specific statement concerning population, anatomy, situation, or conditions of use.  An an example: A titanium plate device that is used for long bone securement in the lower limbs (legs) to provide structural support in adult patients.

This is just a rough example, but indications for use is more specific.  In my own experience, the FDA does not work with intended use, they only work with indications for use.  However, other regulatory agencies use intended use which is usually accepted.  Though over time more regulatory agencies are using indications for use statements, and not using intended use.

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

Original Message:
Sent: 02-Dec-2017 18:31
From: Anonymous Member
Subject: Intended use versus Indications for use

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks

The way I thought about it as a reviewer was this:
Intended Use was what the device was supposed to do in practicality. For example, the device is intended to increase the lumen area of a coronary artery or the device is intended to act as a dura substitute during repair. The indications for use were what the sponsor could support with evidence. This may be very similar to the intended use or be more/less specific. For example, the device is indicated for PTCA of lesions 2.25 - 4.0mm in the coronary arteries or  is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 1.9 in2 or less in area. Those are both examples of indications being more specific, but Ginger cited good points with regards to lasers.

Hopefully that's helpful and not just confusing.

Best,

------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States
------------------------------

Original Message:
Sent: 02-Dec-2017 18:31
From: Anonymous Member
Subject: Intended use versus Indications for use

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks

I hope this helps, intended use and indication for use are sometimes used interchangeably, however I think this helps - Intended use encompasses indication for use as explained by the FDA.

------------------------------
Lin Wu, RAC
------------------------------

Original Message:
Sent: 02-Dec-2017 18:31
From: Anonymous Member
Subject: Intended use versus Indications for use

This message was posted by a user wishing to remain anonymous

​​Hello RAPS members,

I would like to understand the difference between intended use and indications for use. Sometimes intended use and indications for use a used interchangeable and that has confused me. Please help.

Thanks