Can Polyherbal Wound Healing Product be registered as a Medical Device?

M

Manu Chaudhary

#1
I have a query. One of my research products is an excellent wound healer for burns and chronic non healing wounds. It prevents amputation in Diabetic foot ulcer patients. It is a polyherbal product which I want to register as Medical device in US. What could be parallel product for this kind of product? Are there any consultants who guide about predicate products? I have a lot of pre clinical and post marketing surveillance data on this product and safety is established by use in more than 50,000 patients. In which category it be registered as medical device? Kindly guide.
 
Elsmar Forum Sponsor
A

adickerson

#2
Herbal products can be tricky in the USA. If the product is considered a nutritional supplement you get out of a lot of FDA regulation. Once your product becomes a drug used to treat medical condition then it becomes regulated by the FDA. I don't think you could make a paste or ointment a "medical device." It would have to be a drug.

The FDA has a Small Buisness resource that could help answer some questions.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/default.htm

Most importantly you may want to see if the herbs your are using are already an approved drug. If they are then all you are doing is repackaging and the approval process is much easier as it does not contain original drug research. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135688.pdf

That being said, if you don't know the regulations and laws you are going to need some serious professional help. Which of course is going to take a lot of time and money.
 
M

MIREGMGR

#3
Your product will be a drug, not a medical device, unless you can show that it contains no active ingredients and does not act on physiological processes via a pharmacological mechanism.

The point of most "herbal" products is that they contain active ingredients and act on physiological processes via a pharmacological mechanism, so avoiding classification as a drug can be difficult.
 
M

Manu Chaudhary

#4
Your product will be a drug, not a medical device, unless you can show that it contains no active ingredients and does not act on physiological processes via a pharmacological mechanism.

The point of most "herbal" products is that they contain active ingredients and act on physiological processes via a pharmacological mechanism, so avoiding classification as a drug can be difficult.
:yes:
Thanks, for the quote. I have been told by some one (FDA consultant) that it can be registered in 510K as medical device. We are planning to discuss with FDA in next month. I have observed several other registered medical devices for wound closure which are hydrogels or other. I was not sure which one would be a true predicate for my type of product.In my opinion no guidelines restrict registration of herbal product as medical device. Have you had any past experience in similar field?
 
M

MIREGMGR

#5
I have observed several other registered medical devices for wound closure which are hydrogels or other. I was not sure which one would be a true predicate for my type of product.In my opinion no guidelines restrict registration of herbal product as medical device.
USA is in a national-holiday extended weekend, but I'll try to find time when I get to work on Monday to track down an FDA-published Warning Letter that I recall as pertaining to marketing of an herbal wound-care product.
 
M

MIREGMGR

#6
:yes:I have been told by some one (FDA consultant) that it can be registered in 510K as medical device. We are planning to discuss with FDA in next month.
My understanding is that the determinative definitions are here:

A device must be "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory (...)" and must not "achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals (...)."

And: "If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug."

My understanding is that the FDA defines "contrivance" as a mechanical device. I don't know the physical form of your product, but my impression is that it might be an ointment, salve, poultice or bandage of some sort. If you could convince the FDA that the herbal element of your product is insignificant and it's actually a bandage (etc.) with no pharmacologically active ingredients, it might be a device. Such a course, however, would preclude you from marketing it as having special wound care or healing properties, which I gather is the product's point and your goal.

Perhaps we'd understand better if you could share some of your consultant's analysis as to how he/she would get the FDA to consider it a device.
 

yana prus

Involved In Discussions
#7
What could be parallel product for this kind of product? In which category it be registered as medical device? Kindly guide.
Hello Manu,

You should start with classification of your device - just go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm

If you type there "wound", you get all the product codes that refer to the wound treatment. Look for example on the MGQ code - dressing, wound and burn, hydrogel w/drug and/or biologic.

then you can review the 510(k) clearances for this product code - go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
and in the product code type MGQ and you will get the list of the cleared 510(k)s for this product code.

http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092086.pdf - that is the statement for hydrogel from natural oak extract for use as wound dressing to manage diabetic skin ulcers under MGQ code.

Again, in-depth regulatory analysis is required for searching the predicate device, deciding on the indications and claims (like preventing the amputation in Diabetic foot ulcer patients), but I hope I could provide you with some insights where to start from.

Good Luck,

Yana
 
M

MIREGMGR

#8
Note however that clearance for a carrier vehicle (hydrogel, ointment, etc.) under MGQ implies a combination device, with additional clearance from CDER for the pharmaceutical ingredient and/or CBER for the biological ingredient. I'm under the impression that the goal would be to achieve clearance for the described product only as a device.

If however the pharma or bio ingredient(s) are listed (USP or equivalent) for your intended use, the combo device approach could be practical.

A carrier vehicle by itself would be NAE of course, but then you'd be back to convincing the FDA that your significant ingredients don't have any pharmacological or biological effects.
 
Top Bottom