How to Determine Your Medical Device's FDA Classification

Determine Your Medical Device’s FDA Classification Before It’s Too Late

Posted September 14, 2020

In Design Strategy, Medical Product Design

If you’re planning to bring a new medical device to market, your first order of business is to determine how your product will be classified by the Food and Drug Administration.

As you likely already know, the FDA oversees the production of all medical devices in the United States. The FDA’s medical device classifications range from Class I to Class III depending on a device’s intended use and risk level. Knowing your planned device’s classification from the get-go is incredibly important. That’s because it will determine the resources and regulatory controls required to safely and successfully take it to market.

Ready to determine your device’s FDA classification? Here’s what you need to know.

The FDA’s Medical Device Classification System

The FDA recognizes three categories of medical devices: Classes I, II, and III. The difference between each class has to do with a product’s intended use, indications for use, and risk level.

Class I products are low-risk. They are intended to promote health and wellness in a general way (think elastic bandages and tongue depressors).
Class II devices represent medium-risk, non-invasive products. These include things like blood pressure cuffs and pregnancy tests.
Class III includes high-risk devices, most of which are in some way invasive. For example, breast implants and atrial defibrillators are both Class III medical devices.

Is Your Product Technically a Medical Device?

Before you get into the details of medical device classification, you need to take a step back and ask a more basic question. Is your product technically a medical device in the first place?

The FDA defines a medical device as a product that is:

Used to diagnose diseases and other conditions
Intended to cure, mitigate, treat or prevent disease in humans (or animals)
Intended to affect the bodily function or structure of a person (or animal)

Many products — from stethoscopes and knee braces to pacemakers and MRI machines — can be clearly categorized as a medical device based on these criteria. Other products may straddle the line between a consumer product and a medical device depending on the claims you plan to make about them. For example, an electric back massaging device may only cross into medical device territory if you intend to claim that it is capable of treating or mitigating a disease (as opposed to simply soothing non-pathologically sore muscles).

Your intentions for your product should help you easily determine whether or not you have a medical device on your hands.

3 Paths to Determine Your Medical Device’s FDA Classification

Now that you’ve confirmed that your planned product is a medical device, it’s time to figure out how your device will be classified. There are three ways to go about figuring out your medical device’s FDA classification.

1. Compare Your Product to Similar Medical Devices on the Market

The simplest and easiest way to get a sense of your planned device’s FDA classification is to perform a search on the FDA’s database. There you can find information about similar products already on the market, including their medical device classification and the testing protocols they followed as part of their Design Controls package.

Of course, this competitive analysis approach is highly informal and doesn’t come with any guarantees that you’ll make the right assessment. However, it may make sense for you if:

You are already familiar with the medical device development process, including the FDA’s regulatory requirements.
You can clearly identify a similar medical device without any substantive differences that might impact its classification.

2. The Informal, Non-Binding Option: Query the FDA’s Device Determination Mailbox

The FDA offers a free, confidential, and informal device determination service via email. To submit a query, simply email DeviceDetermination@fda.hhs.gov with the following information:

A brief description of your device, including the mechanisms you will use to accomplish your intended use
Your device’s intended use
Any labeling claims you plan to make about your device

The device determination service represents a “quick and dirty” classification. This means that the FDA doesn’t consider its feedback to be a formal ruling on your device’s classification. It is also non-binding, meaning that you are free to change your ultimate submission to the FDA.

The FDA typically responds to these queries within seven business days. However, if your inquiry is more complex, they may require you to submit a formal 513(g) request (see below) before making an assessment about your device.

This informal approach to classifying your medical device may make sense if you want to get an early read on your potential product’s classification before finalizing all the details and beginning the device development process in earnest.

3. The Formal, Binding Option: Submit a 513(g) Request

Finally, the most official method for determining your medical device’s FDA classification is to submit an F13(g) request. This approach, which requires a fee, is both formal and binding.

When you prepare an F13(g) request, you’ll need to include the following:

A cover letter including your specific questions for the FDA
A detailed description of your device, including its mechanism of action, the disease or condition it treats, the patient population it serves, and a picture or schematic (if available)
A summary of your device’s intended use
Your labeling claims

The FDA typically responds to these requests within 60 calendar days by mail. Note that their response doesn’t constitute approval to take your device to market. However, it does offer a formal and binding assessment of your proposed device’s classification.

You may want to take this formal approach if you need absolute certainty about your device’s FDA classification at the outset of your project. For example, if your startup is producing a new medical device with major backing from investors, your investors may rest easier knowing that you are certain about your device’s classification. Because an F13(g) request is binding, you should only go down this path if you are sure about your device’s intended use and major mechanisms.

Regardless of how you go about doing it, determining your medical device’s FDA classification will ensure that your entire team takes the right steps when designing, developing, and testing your new medical device.