February 24, 2021

Is my product a Medical Device? – Knowing the difference


This is an exciting time to be a part of the healthcare innovation sector. It’s advancement, in today’s time, is more than ever before. Many medical devices and consumer healthcare products are making their way into the market. In contrast to the typical consumer healthcare products, like ear buds, nutrition bars, and oral hygiene products; several sophisticated and high-tech consumer products (like Fitbit) are now being introduced. Due to their advanced features and offerings, some consumer products might inadvertently fall under the category of a medical device, which is regulated by different regulatory bodies in different countries, and by the FDA in the US. Typically, any product that treats, diagnoses, cures, mitigates, prevents disease, or affects the body’s structure or function can be classified as a medical device. The FDA gives a detailed definition for a medical device which can be referred to here- Definition.

More often than not, there is an explicit distinction between a consumer product and a medical device, however, in some cases, the distinction is implicit. In the long run, it is always better to have a clear idea about your product type.

Let’s take a few examples here to understand the difference:

  • A pill dispenser, which dispenses pills to a patient, could be mistaken as a consumer healthcare product, but it in fact is a medical device because it releases medication at specified times and intends to improve patient medication compliance
  • A fitness tracker that simply tracks physical activity level and informs about the calories burned, steps are taken, etc, is not a medical device as long as claims that the device is intended to manage a patient’s condition, treat a disease, or provide information that enables the user in making health-related decisions, are not made
  • A software accessory that wirelessly collects, records, and transmits biometric data (including blood pressure, weight, activity level, and pulse oximeter readings) from a variety of home-monitoring devices (including fitness bands) to healthcare professionals for analysis, is definitely a medical device, as the data will assist in self-management of health condition, or for determining the need of medical intervention

If you are developing a healthcare product and are not sure if it is a medical device or consumer product, the following flowcharts will help:

In addition to the above steps, whether or not a product comes under the consumer product or medical device category, has a lot to do with the risks posed by the product, implicit and explicit claims made for the product, and target user, use cases and settings.

After following the above two methods, if you are still unsure about how to classify your device, then we are here to assist you. At Elexes we do a regulatory application, so that you can hear directly from the FDA, whether or not your device is a medical device.

If your product is determined to be a consumer product, it can be sold to consumers right away. However, if it is determined to be a medical device, you might want to do a “Request for information” to identify the product’s class and type of submission (510(k), PMA or De Novo), and then proceed with the respective application and the corresponding testing to submit to the FDA and get a marketing approval.

Making this determination sooner rather than later, will save you a lot of time, money, and not mention, headache, in the long run. So pause and ask yourself, “Is my product a medical device?”

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