Regulatory Open Forum

For your input and perspective....

We purchase a wound dressing (FDA Class II) from an offshore supplier - supplier has an approved 510k and one indication is for "moderate to heavily exuding wounds". Supplier now has a similar dressing we are considering that carries the indication of "dry to heavily exuding wounds" and they want to use the same 510k. I have informed them that, in my opinion, the expanded indication would require another 510k submission to either change the currently approved 510k or get a new 510k for the second dressing using the first 510k as predicate. Supplier's consultants told them no 510k submission is required. Who is right??

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Carroll Hoyle
Sr. Global Regulatory Affairs
Rutherford College NC
United States
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Carroll,

As examples, some dressings are for both dry and moist wounds (e.g., hydroactive wound dressings).  Some dressings are contra-indicated for dry wounds.  Some dressings are for dry to moderately exuding wounds, for light to moderately exuding wounds, for moderate and heavily exuding wounds, or for heavily and extra heavily exuding wounds.

From your description, it would appear that it may introduce a new indication (DRY), which requires a new 510(k).  

For the past thirty (30) years or so, there have been only fourteen (14) adverse events reported from the similar products (e.g., product code KMF).  

A consultant may have chosen to be rather pragmatic (based on the risks) as clients are ready to leave anytime unless they hear what they want to hear. 
 

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President and Principal
http://www.regulatorydoctor.com
Riner VA
United States
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Original Message:
Sent: 09-04-2013 11:06
From: Carroll Hoyle
Subject: Minor Intended Use Change

For your input and perspective....

We purchase a wound dressing (FDA Class II) from an offshore supplier - supplier has an approved 510k and one indication is for "moderate to heavily exuding wounds". Supplier now has a similar dressing we are considering that carries the indication of "dry to heavily exuding wounds" and they want to use the same 510k. I have informed them that, in my opinion, the expanded indication would require another 510k submission to either change the currently approved 510k or get a new 510k for the second dressing using the first 510k as predicate. Supplier's consultants told them no 510k submission is required. Who is right??

-------------------------------------------
Carroll Hoyle
Sr. Global Regulatory Affairs
Rutherford College NC
United States
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Because the device is Class II, design controls apply. Since the supplier considers it the same device, they probably managed it under design changes 830.30(i). As part of their design control system, they should have evaluated the change using the 1997 guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device and created a quality record documenting the decision not to file a new 510(k). Ask for the information.

 

In particular, the evaluation prsumably led them to answer questions B8.1, B8.2, and B8.3 with a No. A Yes answer leads to a new 510(k).

 

For B8.1, the text says, "[I]f the change affects the indications for use, i.e., if it creates an implied new indication for use, a new 510(k) should be submitted."

 

For B8.2, I would expect clinical testing to support the change. This leads to a new 510(k).

 

In short, on the surface it appears the firm needs a new 510(k). However, you need to read the supporting documentation. If they have not documented the decision in detail following the guidance, then I think you have another problem as well.

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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 09-04-2013 11:06
From: Carroll Hoyle
Subject: Minor Intended Use Change

For your input and perspective....

We purchase a wound dressing (FDA Class II) from an offshore supplier - supplier has an approved 510k and one indication is for "moderate to heavily exuding wounds". Supplier now has a similar dressing we are considering that carries the indication of "dry to heavily exuding wounds" and they want to use the same 510k. I have informed them that, in my opinion, the expanded indication would require another 510k submission to either change the currently approved 510k or get a new 510k for the second dressing using the first 510k as predicate. Supplier's consultants told them no 510k submission is required. Who is right??

-------------------------------------------
Carroll Hoyle
Sr. Global Regulatory Affairs
Rutherford College NC
United States
-------------------------------------------

Hello Carroll,

To the best of my knowledge changes in the indications for use section of labeling raise more agency concern than any other aspect of labeling. In fact, most changes in this part of the labeling will require the submission of a 510(k).

I think this is a minor change, and any change in the indications for use that limits use to within the currently cleared indication may occur without the submission of a 510(k). For example, the device was cleared for use with three specific indications and the firm decides to market the device for only two of those indications, would not require submission of a new 510(k).

Also, in different case is where the change expands use to closely related populations.  If the expansion is to a population with similar demographics, diagnosis, prognosis, comorbidity and potential for complications as the original, then a new 510(k) is not ordinarily expected." this might give answer to your question"

In other way i think that, even with a rationale as to how it's 100% assured that the "New indication" can't be different in any significant respect from the original 510K indication, there is a chance FDA will differing with  borderline judgment call.

.
Hope this will help you

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Amit Jain
United States
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Original Message:
Sent: 09-04-2013 11:06
From: Carroll Hoyle
Subject: Minor Intended Use Change

For your input and perspective....

We purchase a wound dressing (FDA Class II) from an offshore supplier - supplier has an approved 510k and one indication is for "moderate to heavily exuding wounds". Supplier now has a similar dressing we are considering that carries the indication of "dry to heavily exuding wounds" and they want to use the same 510k. I have informed them that, in my opinion, the expanded indication would require another 510k submission to either change the currently approved 510k or get a new 510k for the second dressing using the first 510k as predicate. Supplier's consultants told them no 510k submission is required. Who is right??

-------------------------------------------
Carroll Hoyle
Sr. Global Regulatory Affairs
Rutherford College NC
United States
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A neat little case study. I'm more of a PMAer than a 510(k)er, but I can't resist walking through it:

It seems clear that this is an expansion of the indication. And not just in a quantitative way (which sometimes gives you more wiggle room), but in a qualitative way, from exuding to not exuding ("dry.")

My next question is whether the change in indication is clinically meaningful. Given that someone felt the need to specify the level of exuding in the first place, this seems likely.  Whether the clinical impact of the change has the ptoential to be "significant" is something I would want to discuss with the clinical folks.

I would be curious to know what rationale the supplier's consultant provided.

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Julie Omohundro RAC
RAQA Services
Research Triangle Park NC
United States
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A change in labeling affecting indications (especially broadening the indications) requires a new 510(k).  Narrowing the indications (limiting the scope) is a different story.  

Even if a company justifies as part of their design control activity, that is inadequate although it is better than not doing it.  

When a new 510(k) is required but if it is not done so, it can lead to 483s/WL, if found later during an inspection.   

For my training purposes using a practical example (I will be teaching cGMP for devices (QSRs) for the MS program in RA at Northeastern University), I've used an example (a company) here,

If you click through each 510(k) for the similar product of the question in this post, you can see how this company gradually broadened their indications by filing a new 510(k).  

Please note:  Products (requiring 510(k)s and/or cleared through the 510(k) process) are not preempted although class III products (PMAs) are preempted per FDA's review, evaluation and approval.   


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President and Principal
http://www.regulatorydoctor.com
Riner VA
United States
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Original Message:
Sent: 09-05-2013 15:21
From: Julie Omohundro
Subject: Minor Intended Use Change

A neat little case study. I'm more of a PMAer than a 510(k)er, but I can't resist walking through it:

It seems clear that this is an expansion of the indication. And not just in a quantitative way (which sometimes gives you more wiggle room), but in a qualitative way, from exuding to not exuding ("dry.")

My next question is whether the change in indication is clinically meaningful. Given that someone felt the need to specify the level of exuding in the first place, this seems likely.  Whether the clinical impact of the change has the ptoential to be "significant" is something I would want to discuss with the clinical folks.

I would be curious to know what rationale the supplier's consultant provided.

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Julie Omohundro RAC
RAQA Services
Research Triangle Park NC
United States
-------------------------------------------

Hello,

Let's assume(case) it is a broadening of the indication, but that the worst case for the "broadening" is more of the same. Let's focus on this statement from the guidance document, "if the expansion is to a population with similar demographics, diagnosis, prognosis, comorbidity and potential complications as the original, then a new 510k is not ordinarily expected." What would be a good way to document for the expanded indication with the same patient population?

All that I could suggest would be that whatever definitive pathway you used in the original filing, you exactly follow that same pathway in explaining how you can be sure that the population has not significantly changed that's all.

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Amit Jain
United States
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Original Message:
Sent: 09-06-2013 12:06
From: Chang Lim
Subject: Minor Intended Use Change

A change in labeling affecting indications (especially broadening the indications) requires a new 510(k).  Narrowing the indications (limiting the scope) is a different story.  

Even if a company justifies as part of their design control activity, that is inadequate although it is better than not doing it.  

When a new 510(k) is required but if it is not done so, it can lead to 483s/WL, if found later during an inspection.   

For my training purposes using a practical example (I will be teaching cGMP for devices (QSRs) for the MS program in RA at Northeastern University), I've used an example (a company) here,

If you click through each 510(k) for the similar product of the question in this post, you can see how this company gradually broadened their indications by filing a new 510(k).  

Please note:  Products (requiring 510(k)s and/or cleared through the 510(k) process) are not preempted although class III products (PMAs) are preempted per FDA's review, evaluation and approval.   


-------------------------------------------
President and Principal
http://www.regulatorydoctor.com
Riner VA
United States
-------------------------------------------






Original Message:
Sent: 09-05-2013 15:21
From: Julie Omohundro
Subject: Minor Intended Use Change

A neat little case study. I'm more of a PMAer than a 510(k)er, but I can't resist walking through it:

It seems clear that this is an expansion of the indication. And not just in a quantitative way (which sometimes gives you more wiggle room), but in a qualitative way, from exuding to not exuding ("dry.")

My next question is whether the change in indication is clinically meaningful. Given that someone felt the need to specify the level of exuding in the first place, this seems likely.  Whether the clinical impact of the change has the ptoential to be "significant" is something I would want to discuss with the clinical folks.

I would be curious to know what rationale the supplier's consultant provided.

-------------------------------------------
Julie Omohundro RAC
RAQA Services
Research Triangle Park NC
United States
-------------------------------------------