Are you developing a new product and wondering whether it falls under the classification of a drug or a medical device? While some products clearly fit in one classification or the other, with advancements in science and technology, products can have features that blur the lines between drug and device. Navigating the regulatory landscape is often a complex but critical aspect of bringing your innovation to market. In this series, we will explore the regulatory mechanisms available to help you distinguish a medical device from a drug product and to utilize FDA’s regulatory pathways specific to each, particularly in early development. Understanding the differences between these 2 product classes is not only essential for regulatory purposes but also crucial for ensuring that the safety and efficacy of your product is evaluated in an appropriate manner.

First and foremost, it is important to note that in the US the decision on whether your product will be evaluated as a drug or a medical device, or even a combination product (not further discussed in this post), will ultimately be made by the FDA. To guide this decision, the definitions of a drug and a device are defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 201 (Title 21 USC 321), which states that the term “drug” means:

• recognized in the Official US Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;
• intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;
• (other than food) intended to affect the structure or any function of the body of man or other animals;
• intended for use as a component of any article specified in (A), (B), or (C) above.

and the term “device” means:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-

(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(B) 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

(C) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve 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 its primary intended purposes.

From these definitions, it is clear that a product is distinguished as a drug or a device based on its primary mode of action. While drugs act via a chemical or pharmacological action within the body, devices use mechanical or technological mechanisms to elicit their effect. Thus, a key first step for a Sponsor before having any interaction with the FDA is compiling ample data to support your product’s primary mechanism of action.

For some products, this is as simple as it looks on paper. For instance, insulin is clearly a drug because it binds to the insulin receptor on cells and activates chemical pathways to regulate blood glucose levels. In contrast, a blood glucose monitor is clearly a device because it helps people monitor blood glucose levels but does not cause a chemical change in the body. However, the FDA recognizes that some products are not so clearly classified, and distinguishing between a drug and a device can be a challenging task, even for experts. There are processes in place for Sponsors to seek the FDA’s input on how their product should be classified, the key one being the Request for Designation (RFD) process, which we will explore more in future posts in blog series. Additionally, to provide some clarity on product classification, a guidance entitled, “Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff” (September 2017) was published to help Sponsors and regulatory professionals. This guidance expands on the definitions above to further explain key terms in the definition of device, such as “primary intended purposes” and “chemical action.” It also provides examples of drug and device products and offers guidance on obtaining a formal determination of a product’s classification via the RFD process. As pointed out in this guidance, products that meet the drug definition and that also meet the definition of biological product are classified as biological products and are generally subject to licensure under the Public Health Service Act. Another resource entitled How to Determine if Your Product is a Medical Device (September 2022) provides several steps to help a Sponsor decide whether your product will be regulated as a medical device.

In our next blog post in this series, we’ll dive into various regulatory processes to help provide a roadmap to assist as you navigate the intricacies of bringing a new product to market.

Sarah Dulson, PhD, Integrate Product Development Associate, has over 10 years of experience in scientific research and writing, complemented by a year in Regulatory Strategy and Biometrics at Rho. Her work in regulatory strategy includes authoring and assisting in the development of modules for regulatory submissions (IND, NDA, BLA, etc), documents crucial for FDA meetings, clinical study protocols and reports, and regulatory guidance memos. Dr. Dulson has supported regulatory activities for drug and device products across a diverse range of indications from general anesthesia to vaccines to hair growth, and she functions as a valuable resource for clients navigating product development to bring their product to market.