Is My Product a Medical Device?
I get asked this question quite a lot. It’s important to understand the criteria of what constitutes as a medical device and how medical devices are classified so that the proper regulatory pathway is taken for pre-market clearance or approval, as well as saving yourself the trouble of going through 510(k) or PMA if your device only requires FDA registration, should really be considered a general wellness device, or something else.
You can watch this CDRH module video from the FDA in which CDR Kimberly Piermatteo, MHA describes how the FDA defines a medical device, reviews topics to consider when deciding on a regulatory pathway and walks through ways you can get formal and informal FDA assistance throughout the process, or you can continue reading as I summarize the module to provide insight on how to define your device so you can bring it to market.
First, we should look at how the FDA defines a medical device.
How Does the FDA Define a Medical Device?
Section 201(h) of the Food, Drug & Cosmetic Act (FD&C Act) defines a 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 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 520(o).
Know Your Product.
To understand if your device meets the criteria of a medical device as described above, you need to make sure that you truly understand your product and can answer the following:
- What is the intended use of the product?
- How does your product function?
- What claims do you intend to make?
How Do I Define the Intended Use?
It is key to be able to understand and define your intended use to properly be able to classify your device. To do this:
- Clearly state the general purpose or its function
- Further describe:
- The disease or condition the product will diagnose, cure, mitigate, treat, or prevent
- The intended patient population
If, when answering these questions, you find that the intended use of your device is consistent with the definition of a medical device above, you will have to be classified as a medical device and will be subject to pre-market and post-market regulatory controls. This sometimes makes clients uncomfortable as they would prefer to not be subjected to such controls and will look for ways to define their device as something else, such as a general wellness device, but it’s important to be honest about your intended use and truly assess whether it meets the criteria of a medical device. Not doing so could cause you to mislabel or market your device, which can lead to safety and regulatory concerns down the road.
Is There an Existing Product Classification?
One of the simplest ways to understand how to properly classify your device or to know if it should be regulated as a medical device is to look for an existing FDA medical device classification that matches the intended use or design of your device. This can be done by checking with the publicly available FDA Product Classification Database.
In this database, you can search various fields, such as:
- The FDA product code
- Regulation number
- Device class
It is recommended that users use the Quick Search function to search the database by keywords which will give you a broad range of classifications, which can then be narrowed down to the classification that is most appropriate for your device. As a general rule, if you have an existing classification, your device meets the criteria of a medical device and will likely need pre-market clearance or approval through 510(k) or PMA.
Special Considerations to be Considered When Determining if Your Device is a Medical Device.
- In Vitro Diagnostics (IVDs), which are used to sample blood, tissue, etc. for the diagnosis or treatment of diseases, are regulated as medical devices. Examples of IVDs would include things like home pregnancy tests or glucose test strips. IVDs are characterized by the FDA as:
- Reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions.
- Collect, prepare, and examine specimens taken from the human body
- Can be used in a laboratory, health professional setting or at home
- Most radiation-emitting products are not considered medical devices, but some radiation-emitting products with medical applications and claims meet the definition of a medical device and are regulated as such. Examples of radiation-emitting devices might be diagnostic ultrasound, medical lasers, or X-Rays. Section 531 of the FD&C defines an electronic product as:
- A product which when in operation (i) contains or acts as part of an electronic circuit and (ii) emits electronic radiation.
- If you have a mobile app that is performing medical functions, regardless of the platform from which it is run, it will likely meet the criteria of a medical device. The FDA focuses on subset of apps for regulation known as MMAs (Mobile Medical Applications), which pose the highest risk to users if not functioning as intended. You can find FDA guidance on MMAs HERE.
- Software that is intended to be used for medical purposes may be considered a medical device, which the FDA refers to as SaMD, or Software as a Medical Device. Examples of SaMD might be a software application that allows a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for diagnostic purposes. The FDA defines SaMD as:
- “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”
- If your device is actually a general wellness product, it may not be considered a medical device and may not need to be regulated as such. You can read the FDA guidance on low risk general wellness products HERE. For a device to be considered a general wellness product, it must meet the following two factors:
- The device is intended for only general wellness use, as defined in the guidance above, and
- Presents a very low risk to users’ safety.
- Combination products – such as drug eluting stents, heparin coated dialysis catheters, or first-aid kits that include drugs – are defined by 21 CFR 3.2 ( e ) as:
- Therapeutic and diagnostic products that combine drugs devices, and/or biological products
- Lead center is based on a determination of the “primary mode of action” (PMOA)
Making the Final Determination.
Now that we’ve covered how the FDA defines a medical device, how you can better understand your device and its intended use to compare to the criteria for a medical device, how to search the FDA database for existing classification for similar products, and what special considerations you might need to take into account to make the determination as to whether your product is a medical device, I’ll conclude with a table of questions to ask to make the final determination. I’ve filled in the table to reflect the FDA definition of a medical device; if you answer yes to any of the questions that currently have an ‘x’ in the ‘YES’ column, for instance, your product is likely a medical device that needs to be regulated. If you determine with the table that your product is a medical device, you’ll need to determine class (I, II, or III) to understand the appropriate pathway, whether you need registration only, or if you will need a pre-market notification with a 510(k) or pre-market approval (PMA), which I will discuss in detail in another post.
As always, you can reach out to me HERE to discuss questions that you might have.