“How do I know if my product is a drug or a device?”
This is the million dollar question, or approximately a 2 million dollar question, considering the application for a drug will cost you around $2.6M, whereas a device costs around $350K. And the differences in the cost of development far exceed that. Needless to say, this can make or break your budget and the interest of investors.
Now, all products marketed to diagnose or treat a disease, or to alter the structure or function of the body, require some level of oversight by the FDA...
But how a product accomplishes the intended effect great affects the amount of oversight and development required for your product's approval or clearance.
So, how can you get some answers and feel confident in the pathway that you pitch?
There are a few steps you can take...
Take a look at the definitions outlined within the Federal Food, Drug, and Cosmetics Act (FD&C Act):
The FD&C Act (21 USC 321(g)) defines the term drug as “articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C).”
And it defines a device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
Yikes! That’s quite a mouthful, so what it essentially boils down to is this: Drugs achieve their intended effects via chemical interaction or metabolization in the body, and devices don’t.
A common place for confusion? Nanoparticles.
So, let’s break this down into some examples:
Example 1: Gold nanoparticles used in conjunction with ultrasound to treat a tumor through the generation of excessive heat.
This is a device.
Why? This mode of action is primarily physical, not chemical. The ultrasound stimulates to the nanoparticles producing heat which kills the tumor cells. The gold nanoparticle itself is not having a direct chemical action on the tumor cells.
Example 2: Gold nanoparticles modified with a ligand to induce internalization of the nanoparticles into the cell.
This is a drug.
Why? In this case, the gold nanoparticles cause cell death through an interaction with an internal cellular process, meaning a chemical action.
Example 3: Absorbable sutures.
Why? Despite the polymer being degraded and absorbed by the body, its primary action is through holding the wound closed and not a chemical action of the polymer.
What else can you take into consideration?
Past precedence. Take some time to compare your product to similar or related products that have already been cleared or approved to gain some insight on what might be required for your product.
But man, sometimes things are still just not clear, which leaves you to wondering...
"Can't FDA just tell me how to regulate my product?"
The answer is that they can, but you should proceed with caution.
If you want the FDA's final designation for your product, you may submit a Request for Designation (RFD) to The Office of Combination Products for review. FDA must respond to an RFD within 60 days or the product is classified as determined by the sponsor's initial recommendation.
That all sounds great. But, here's the thing about RFDs, they are BINDING, which means if you don't get the designation you want, you’re likely stuck. And that's a lot of money and time to be stuck with having to gain. OOF! So what can you do to get the FDA's feedback?
Well, the pre-RFD is here to save the day, and we recommend companies struggling with classification determination use this avenue.
What is the pre-RFD, and why do we recommend it?
The pre-RFD is a way for you to get preliminary designation for your product from the FDA without being bound to their feedback. This means that, unlike the RFD, a pre-RFD is not final. It does, however, give you insight into the FDA's thoughts on your product classification. Should you disagree with the result of your pre-RFD? You're able to contact and discuss this with the FDA, so that you can address the concerns prior to submitting a new Pre-RFD or the more formal RFD. This could help get things moving in the direction you want. Overall, the benefit here is pretty good in that you can get some solid understanding on how the argument you’re presenting is being viewed by the FDA so that you can modify to get a more favorable outcome in the future. Win!
How can Proxima help?
Proxima Clinical Research offers services to help at every stage in biologic, drug, and device development, which means we know our way around all possible designations. So, if you have questions about how your product may be regulated, RFDs, or just need help navigating the industry, reach out through our help desk to chat with a specialist or leave a message. We love startups, and we’d love to help you with your development!