Regulatory Open Forum

Ann,
I believe that the best route really depends on your indications and claims.  Regarding the DeNovo path, for borderline products I would suggest a pre-RFD first.  If you start with a Q-Sub for the DeNovo route, there is a very high likelihood of you ending up with a jurisdictional letter saying that you have been deemed to have a drug PMOA and should submit an RFD.  Starting with the Pre-RFD saves you that 1-2 month turn around and doing the "Pre" route gets you feedback without being locked into a designation if your first attempt results in a designation that you didn't desire.  For the RFD, be very careful with your indications.  I suggest you look at the capsular decisions for both CDRH and CDER to know what wording will have you end up where. Here is the link if you aren't familiar with where to find them: https://www.fda.gov/combination-products/classification-and-jurisdictional-information/rfd-jurisdictional-decisions

Good luck! Combination products are a world of their own!
Jayme

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Jayme Calhoun
VP of Regulatory Affairs
Saint Johns FL
United States
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Original Message:
Sent: 10-Mar-2020 17:03
From: Ann Kemp
Subject: Combination Product

Hi,

I am looking at a combination product that would be composed of a hydrogel and an antimicrobial. 

One proposal is to have the 2 products in a kit. I think that is not acceptable.  

If packaged together in a kit, there would there have to labeling to address the reason they are kitted, correct?  

I proposed submitting as separate cross labeled products. In 2008 a 510(k) was submitted (company under different ownership) for this. There were many questions and the company opted not to pursue the 510(k). The initial response from FDA stated that FDA was looking into whether the hydrogel would be a drug delivery device.  Also no known predicate for the hydrogel. This hydrogel is a powder that when applied to the wound absorbs exudate and forms a gel like covering. I cannot find a predicate either.

Should I pursue De Novo?

Any input would be appreciated.

Thanks. 

Ann E Kemp

Regulatory and Quality Services, LLC

1635 Juno Ave

St Paul, MN 55116

612-730-0217

a26kemp@gmail.com

I would go right to an RFD; or else cite the examples below. There are plenty of predicate decisions for a wound covering and an exudate absorder as a medical device. In that case, the anti-microbial would not be the primary mode of action, and you would be a device in CDRH with a microbial consult in CDER. Kinda like a heparin-coated device.

I could be wrong, and the anti-microbial is the primary mode of action, but if its for prophylaxis, I think it's a device.

See example 4 here:
https://www.fda.gov/combination-products/about-combination-products/combination-product-definition-combination-product-types

and the capsular decisions here: RFD capsular decisions > Capsular Decisions - Products Assigned to CDRH

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States
------------------------------

Original Message:
Sent: 10-Mar-2020 17:03
From: Ann Kemp
Subject: Combination Product

Hi,

I am looking at a combination product that would be composed of a hydrogel and an antimicrobial. 

One proposal is to have the 2 products in a kit. I think that is not acceptable.  

If packaged together in a kit, there would there have to labeling to address the reason they are kitted, correct?  

I proposed submitting as separate cross labeled products. In 2008 a 510(k) was submitted (company under different ownership) for this. There were many questions and the company opted not to pursue the 510(k). The initial response from FDA stated that FDA was looking into whether the hydrogel would be a drug delivery device.  Also no known predicate for the hydrogel. This hydrogel is a powder that when applied to the wound absorbs exudate and forms a gel like covering. I cannot find a predicate either.

Should I pursue De Novo?

Any input would be appreciated.

Thanks. 

Ann E Kemp

Regulatory and Quality Services, LLC

1635 Juno Ave

St Paul, MN 55116

612-730-0217

a26kemp@gmail.com

I agree with Andrea and Jayme, that a RFD to the Office of Combination Products is the safest path.

------------------------------
Liliana Chocarro
Consultant
MISSISSAUGA ON
Canada
------------------------------

Original Message:
Sent: 10-Mar-2020 17:03
From: Ann Kemp
Subject: Combination Product

Hi,

I am looking at a combination product that would be composed of a hydrogel and an antimicrobial. 

One proposal is to have the 2 products in a kit. I think that is not acceptable.  

If packaged together in a kit, there would there have to labeling to address the reason they are kitted, correct?  

I proposed submitting as separate cross labeled products. In 2008 a 510(k) was submitted (company under different ownership) for this. There were many questions and the company opted not to pursue the 510(k). The initial response from FDA stated that FDA was looking into whether the hydrogel would be a drug delivery device.  Also no known predicate for the hydrogel. This hydrogel is a powder that when applied to the wound absorbs exudate and forms a gel like covering. I cannot find a predicate either.

Should I pursue De Novo?

Any input would be appreciated.

Thanks. 

Ann E Kemp

Regulatory and Quality Services, LLC

1635 Juno Ave

St Paul, MN 55116

612-730-0217

a26kemp@gmail.com

Keep in mind that a combination product is two regulated products. If the hydrogel is just delivering the antimicrobial then you only have one regulated product. If the hydrogel has another purpose then you have two products. But are they two products in two different centers? A combination of two drugs is not a combination product. It is a drug

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States
------------------------------

Original Message:
Sent: 10-Mar-2020 17:03
From: Ann Kemp
Subject: Combination Product

Hi,

I am looking at a combination product that would be composed of a hydrogel and an antimicrobial. 

One proposal is to have the 2 products in a kit. I think that is not acceptable.  

If packaged together in a kit, there would there have to labeling to address the reason they are kitted, correct?  

I proposed submitting as separate cross labeled products. In 2008 a 510(k) was submitted (company under different ownership) for this. There were many questions and the company opted not to pursue the 510(k). The initial response from FDA stated that FDA was looking into whether the hydrogel would be a drug delivery device.  Also no known predicate for the hydrogel. This hydrogel is a powder that when applied to the wound absorbs exudate and forms a gel like covering. I cannot find a predicate either.

Should I pursue De Novo?

Any input would be appreciated.

Thanks. 

Ann E Kemp

Regulatory and Quality Services, LLC

1635 Juno Ave

St Paul, MN 55116

612-730-0217

a26kemp@gmail.com

I would agree with Andrea here on two separate points:

1. Your hydrogel does have at least one predicate on the market.  I know this because in a previous company I was working on a review of the space to determine if there was a good ProCode to use for a new product we were looking to launch.  Also, keep in mind that "hydrogels" tend to act as a covering to specifically release material onto the body while "hydrocolloids" tend to absorb exudate from a wound.  So be very careful about your terminology.

2. If the only purpose for the covering is to ultimately deliver the antimicrobial active ingredient then the covering is a delivery mechanism and likely doesn't create a combination regulated product - I would suspect it would be simply considered a drug product with a delivery system.  If your claims make reference to absorbing exudate or protecting wounds in some way then you have edged into what I would suspect would be a combination product which would require a determination by FDA as to the proper MOA to properly assign the lead center in the agency as well as any necessary consultations.

Remember, like everything else, the real key to these questions ultimately is what you say about the product's abilities and how the product works.  This is what will be used to determine what happens so the more carefully crafted the indications the more confident you can be in your decision as to where the product will be reviewed and what regulations might apply.

------------------------------
Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
------------------------------

Original Message:
Sent: 29-Apr-2020 09:10
From: Andrea Chamblee
Subject: Combination Product

Keep in mind that a combination product is two regulated products. If the hydrogel is just delivering the antimicrobial then you only have one regulated product. If the hydrogel has another purpose then you have two products. But are they two products in two different centers? A combination of two drugs is not a combination product. It is a drug

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States

Original Message:
Sent: 10-Mar-2020 17:03
From: Ann Kemp
Subject: Combination Product

Hi,

I am looking at a combination product that would be composed of a hydrogel and an antimicrobial. 

One proposal is to have the 2 products in a kit. I think that is not acceptable.  

If packaged together in a kit, there would there have to labeling to address the reason they are kitted, correct?  

I proposed submitting as separate cross labeled products. In 2008 a 510(k) was submitted (company under different ownership) for this. There were many questions and the company opted not to pursue the 510(k). The initial response from FDA stated that FDA was looking into whether the hydrogel would be a drug delivery device.  Also no known predicate for the hydrogel. This hydrogel is a powder that when applied to the wound absorbs exudate and forms a gel like covering. I cannot find a predicate either.

Should I pursue De Novo?

Any input would be appreciated.

Thanks. 

Ann E Kemp

Regulatory and Quality Services, LLC

1635 Juno Ave

St Paul, MN 55116

612-730-0217

a26kemp@gmail.com

Hi Ann,
It sounds like you definitely have a  combination product per 21 CFR Part 4, as you would be copackaging the two products..  The pathway you take is dependent on the claims.  Are you primarily a hydrogel (or hydrocolloid per Victor) wound dressing that has an antimicrobial feature or are you an antimicrobial drug that is delivered via a hydrogel that becomes the wound dressing?  This is reminds me of the drug-eluting stent dilemma; which is the PMOA the drug or the stent?  

I think your first step is to definitively determine your intended use and claims, and then proceed based on making your arguments that the claims are primarily device PMOA or drug PMOA.  Second step would be to investigate Victor's hydrocolloid predicate.  And then keep us posted.  I love the combination product world! 
Good Luck.
Sara

------------------------------
Sara Coon
Director, Regulatory Affairs
MN United States
------------------------------

Original Message:
Sent: 10-Mar-2020 17:03
From: Ann Kemp
Subject: Combination Product

Hi,

I am looking at a combination product that would be composed of a hydrogel and an antimicrobial. 

One proposal is to have the 2 products in a kit. I think that is not acceptable.  

If packaged together in a kit, there would there have to labeling to address the reason they are kitted, correct?  

I proposed submitting as separate cross labeled products. In 2008 a 510(k) was submitted (company under different ownership) for this. There were many questions and the company opted not to pursue the 510(k). The initial response from FDA stated that FDA was looking into whether the hydrogel would be a drug delivery device.  Also no known predicate for the hydrogel. This hydrogel is a powder that when applied to the wound absorbs exudate and forms a gel like covering. I cannot find a predicate either.

Should I pursue De Novo?

Any input would be appreciated.

Thanks. 

Ann E Kemp

Regulatory and Quality Services, LLC

1635 Juno Ave

St Paul, MN 55116

612-730-0217

a26kemp@gmail.com