FDA Regulations

Is your product a medical device?

Are you unsure if your product is a medical device? From an adult diaper to an MRI machine, some surprising products are classified medical devices. Determining if your product is a medical device is not always as simply as you may think. Read on for a better understanding of your product’s status.

The Food and Drug Administration (FDA) has both defined medical devices and outlined the steps to determine whether a product fulfils the parameters or not. The FDA defines a medical 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 its primary intended purposes through chemical action within or on the body of man or other animals
  • The term “device” does not include software functions excluded pursuant to section 520(o)”

So, any product that fulfils the above definition can be classified as a medical device. However, a product’s status can change based on its’ evolution and additions.

To further aid in your determination of your product’s stats. The FDA has outlined the following steps:

  • Determine if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act: Define the intended use of the product and how it will function to achieve the intended goal. You also need to provide description of the disease or condition it intends to diagnose, cure, mitigate, treat or prevent along with the target patient population.
  • Determine if an appropriate product classification exists for your product: Once your product matches the definition, the next step is to find out if any appropriate product classification is already available. For this, you can access the Product Classification Database. If your product’s intended use and design matches with that of an existing classification, it becomes easier to determine if it is a medical device or not.

After evaluating these two points you should have a better idea of your product’s medical device status and its associated go-to-market strategy.

If you’re still unsure reach out to our team of experts at Prime Path Medtech to delve deeper and have a better understanding of your product.