There’s a wide range when it comes to medical devices and so we wanted to pull together this simplified guide that could help you determine if your product is regulated by the FDA as a medical device. Let’s begin by sharing some definitions and pointers, so your team can move forward as efficiently as possible.
Ok, what is a medical device?
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 and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
What does your product do and who is it for?
To determine if your product meets the definition of a medical device, you should start with defining the intended use and indications for use of your product.
- Intended Use - the general purpose of the device or its function. This includes the indications for use
- Indications for Use - Describes the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended.
For your reference: Definition of "medical device" per Section 201(h) of the Food, Drug, and Cosmetic Act for full details is shown below:
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 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 520(o).
Is there an existing classification that might apply to your product?
It may also be helpful to search for existing product classifications that may apply to your product. Finding an existing classification that describes your product’s intended use or design is a good indicator that it might be a medical device as well as give you a good idea what the FDA expects in a possible regulatory filing. Try these three methods.
Method 1: Search the Product Classification Database
Try searching the FDA Product Classification Database to determine if there is an existing product classification that applies to your product:
- Use the Quick Search feature to search by keyword(s). Helpful tip: you might want to conduct multiple searches using a mix of keywords that describe your product (e.g., search both “stent” and “stents”).
- Use the Advanced Search feature to search by product code, regulation number, device class or other relevant data.
Method 2: Search for Similar Devices
If you find a similar device legally marketed in the United States, try searching for a FDA letter or order that permits market authorization. The information in the letter or order for a similar device type could be a help you figure out the classification of your device.
Try searching the following databases, using either the Quick Search or Advanced Search feature:
- Premarket Approval (PMA) – Most Class III (high risk) devices require Premarket Approval (PMA) before they may be legally marketed. This database includes devices with Premarket Approval, and includes the approval order, Summary of Safety and Effectiveness, and labeling for the approved device (original PMAs and panel-track supplements).
- Premarket Notification 510(k) – Most Class II (moderate risk) devices require 510(k) clearance from the FDA before they may be legally marketed. You can also filter for previous FOIA requests.
- De Novo – De Novo provides a possible route to classify novel devices of low to moderate risk. This database includes De Novo classification orders and transparency summaries.
- Humanitarian Device Exemption (HDE) provides a possible route to market medical devices that may help people with rare diseases or conditions. This database includes devices with HDE approval, and includes the approval order, Summary of Safety and Probable Benefit, and labeling for the approved device.
Helpful tip: Most Class I and some Class II devices may not be listed in the databases referenced above because they are exempt and do not require the FDA’s review before marketing.
Method 3: Search for Similar Devices by Device Listing
You might also want to search for a legally marketed device’s product classification by reviewing its device listing information. Device listing information can be found by searching the FDA’s Establishment Registration and Device Listing database, using either the Quick or Advanced Search feature.
For your reference: If you would like a formal device determination or classification from the FDA, you can try submitting a 513(g) Request. For instructions on how to do that, refer to the guidance document FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act Guidance (2012).
Is your product a Mobile Medical Applications or a Software as a Medical Device?
Let’s begin with basic definitions. The FDA considers mobile medical applications or “mobile app” as a software application that can be executed (run) on a mobile platform (i.e., a handheld commercial off-the-shelf computing platform, with or without wireless connectivity), or a web-based software application that is tailored to a mobile platform but is executed on a server.
You can check out the Mobile Medical Applications page on mobile medical applications and how they are regulated.
The FDA considers software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device to be software as a medical device. More information is available on the Software as a Medical Device page.
If you are still unsure whether your product would be considered a mobile medical application or software as a medical device, you can contact email@example.com. It is recommended to provide a clear description of your product, its intended and indications for use, and other relevant information that helps the FDA understand exactly what your product is. Keep it short and sweet i.e. 2-3 pages.
Is your product intended for General Wellness?
If your product is intended for general wellness use only, and is low risk, it may not be actively regulated by FDA. Check out the FDA’s guidance document General Wellness: Policy for Low Risk Devices.
Does your product include drugs or biologics?
Combination products are therapeutic and diagnostic products which combine drugs, devices and biological products. If you think your device may fit into this category, check out the FDA Combination Products page.