MedTech Compliance Chronicles: Navigating FDA Regulations

Is your product a Medical Device?

Good evening to all and welcome to the MedTech Compliance Chronicles: Navigating FDA Regulations blog. As this is our first post in this series I will begin with a brief introduction of myself and the plan for this blog. I achieved my bachelor’s degree in Biomedical engineering in the beginning of 2017 and, after a brief tenure as a Marine Officer, began working in Quality Management in the medical device sector toward the end of 2020. I have moved relatively fast thus far in my career and have spent the last few months of 2023 contemplating how I can be sure that I consistently keep myself updated with the requirements of my industry. That desire along with a curiosity to fully close the loop in my knowledge of regulatory requirements led me to creating this blog. Thus far in my career I read over 21 CFR Part 820 many times and delved into other parts as they became pertinent to my current work. However, for years now I have wondered, and for months I have been searching for a way, other than waiting for each scenario to become relevant to my current role, to expand my learning to know the details and what must be done at every interaction a business has with the FDA. 

This blog is to be a detailed guide where I will assume the identity of a fresh new company marketing a single new product that they just learned might be a medical device regulated by the FDA. I plan on taking you through the entire process, from determining your product is a medical device regulated by FDA to releasing the device to market and implementing post-market activities and everything in between. I would very much like for this to be a perfect guide that a new MedTech start-up could follow in-lieu of consulting services to meet FDA requirements, however, as it is primarily a professional development exercise for me I welcome any and all criticism and feedback. Let us begin this journey together, get ready to travel the road to regulatory compliance!

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Determining if Your Device is a Medical Device

The very first step in this journey may seem almost too obvious to those of you who began designing your device knowing they were medical devices from the get-go but that is not the case for all. Many products start off not intended to be medical devices but then after really laying out the intended use of the device and finishing their marketing material they begin to potentially make medical claims that could make it such that they are required to be regulated by FDA. We will start with the simplest place to start and break things down from there. What exactly constitutes a medical device?

The Official Definition of a Medical Device

Now, if you are like me, you probably wanted the official definition of medical device from an actual regulation, not just a guidance document. I have seen the ‘official’ definition many times in guidance documents but it never appeared in the defined terms of the regulations I read through. I looked all through title 21 unable to find it and finally I found it in 21 U.S. Code § 321(h). The official definition of ‘Medical Device,’ as provided by the FDA is:

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.

The term ‘‘device’’ does not include software functions excluded pursuant to section 360j(o) of this title.

Analysis

We will start our analysis by first ridding ourselves of that last sentence. Section 360j(o) of Title 21 basically applies to software used by healthcare facilities that are not pertinent to diagnosis or treatment of patients. It can range from the healthcare facility’s administrative systems to electronic storage of basic patient information. The key difference to keep in mind when deciding if a software function is to be considered part of the medical function of a device is whether the software is involved in or relays information pertinent to the treatment or diagnosis of the patient. Basic medical history of the patient is generally not considered information pertinent to treatment or diagnosis. 

Now, from the first part of the definition (instrument, apparatus, machine etc.), we can deduce that pretty much anything that can be made can be a medical device. So what makes something a medical device? This is where two very important terms that will arise many times throughout your regulatory journey come into play; intended use and indications for use. Unfortunately, neither term is officially defined by FDA nor an exact list of requirements for intended use of indications for use laid out. This is because of the wide range of applications and things that can fall under the term medical device, as well as the fact that the world is constantly changing with new technology and disease but I will now provide some guidance on how to approach these topics.

First, we will start with ‘intended use.’ As one of my first bosses and early mentors said “everything comes down to intended use.” If you look at points (B) and (C) of the definition of medical device both start with this word “intended,” showcasing that it really is how the manufacturer intends for the device to be used and what they will claim as benefits of use when marketing the device that is the ultimate determination of whether or not the device is a medical device or not. Basically, no matter what product you have made, if you intend and/or make claims of it curing, mitigating, treating or preventing any disease or support or alter any body structure or function, and it does not achieve this intent primarily through pharmacological or metabolic means, your product is a medical device.

Our final point in determining if your product is a medical device is in examining the indications for use. Some products have no direct medical purpose but are marketed to people with specific medical conditions because their conditions give them special needs. In some cases, these types of products can also be considered medical devices by the FDA. Alternatively, certain claims on a product can push it into the medical device spectrum. Some examples of where you might want to be careful walking the borderline (if you do not want your product to be a medical device) is in developing certain health apps or wearable devices. You want to be very careful with any claims you make in regards to tracking bodily functions (heart rate, sleep, etc.) and any diagnostic potential of the device. Remember, if it is just a fun app to get a general idea of your fitness level and no claims are made about the accuracy or effectiveness of the technology at mitigating or treating ‘X’ aliment, you are probably in the clear. However, per the definition, the second any claim of alleviation, mitigation, treatment or cure begins to creep into the marketing, you are now in medical device territory and must comply with all applicable regulations in order to continue to make those claims. A final point on this topic that is not particularly pertinent to determining if your product is a medical device but, if it is, will help you legally later on, is determining contraindications. Contraindications are any conditions a person may have that make them unable or at high risk to use a particular type of device, examples would be someone with metal implants not being able to use an MRI machine.

I will make a final point about point (A) of the definition for those who are wondering. Recognition in the official National Formulary or United States Pharmacopeia is not pertinent to determining if your product is considered medical device. Rather, depending on the type of device it is, it may require recognition in the official National Formulary or United States Pharmacopeia. Usually this applies to devices that incorporate a drug to some degree or where purity of a particular substance is of concern.

Conclusion

To summarize, the first step in the regulatory pathway with FDA is making sure that you actually need to go down the path in the first place. The official FDA definition of Medical Device is the best place to start and work off. After you have a solid understanding of the definition you then need to really example your product, what you want your product to do, how you want your product to be used and who you want to use your product. All of these things can play a role in determining if your product is a medical device or not.

Thank you all for joining me on this first iteration of this new journey. I hope you will all join me next week to learn about device classification!