Watch Our Weekly Webinar: MedTech Crossroads

All medical devices in the United States are regulated by the Food & Drug Administration (FDA), and understanding the FDA’s definition of a medical device as well as how the agency classifies medical devices is a crucial part of learning how to bring your medical device to market.

FDA Medical Device Definition: What Does the FDA Consider 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 of 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.”

To determine whether your product meets the FDA definition of a medical device, you should first identify the intended use (what the medical device does) and indications for use (the condition or disease the medical device will diagnose, cure, mitigate, treat, or prevent) of the device. Then, you can see if your device falls under the FDA’s definition.

What Are FDA Medical Device Classifications?

The FDA’s Center for Devices & Radiological Health (CDRH) categorizes all medical devices marketed in the United States into three broad classifications: Class I, Class II, and Class III.

Each classification comes with its own set of rules that determine how devices can be marketed, from what requirements product manufacturers must follow to what actions they must complete before the device can be sold on the market.

Medical Device Classes: What Are Class I, II, and III Medical Devices?

Classifications are generally assigned to medical devices based on both potential risk to the patient and the level of FDA regulatory control required to market the device. As the classification level increases, so does patient risk and regulatory control.

Class I Devices

Medical devices in the Class I category have the least amount of regulatory control and minimal potential harm to the patient. These devices are relatively simple to design, manufacture, and use. Examples of Class I medical devices are hospital beds, oxygen masks, tongue depressors, and arm slings.

Class II Devices

Class II medical devices require more FDA regulation to assure safety and effectiveness. X-ray systems, contact lenses, syringes, and blood transfusion kits all fall under this medical device classification.

Class III Devices

Products used to support or sustain human life or those that present a potentially high risk for a patient are in the Class III classification. These devices are, understandably, more rigorously regulated than Class II or Class I products and require additional levels of approval. Heart valves, cochlear implants, and defibrillators are examples of Class III medical devices.

What Are the Differences in FDA Medical Device Classifications?

Other than the level of patient risk, the most significant difference among FDA medical device classifications has to do with the path to marketing for manufacturers. The class to which a device is designed determines what is required before the FDA will clear the product for market in the United States.

Path to Market: Class I Devices

Class I devices must follow basic guidelines called General Controls. These controls include rules relating to a variety of provisions, such as misbranding, device registration, and good manufacturing practices.

Path to Market: Class II Devices

Class II devices have to abide by Special Controls in addition to General Controls. These additional controls cover areas such as special labeling requirements, surveillance after the product is on the market, and mandatory performance standards. Additionally, Class II devices often require the pre-market submission and FDA review of a 510(k) clearance.

Path to Market: Class III Devices

Class III devices are the most stringently regulated, so much so that General and Special Controls are not sufficient. While devices in this category must meet General Controls, the FDA typically requires Premarket Approval (PMA) submission as well, which is an additional level of scientific and regulatory review that must be obtained prior to marketing the device. In some cases, a 510(k) is required instead of PMA.

Medical Device Regulatory Classification in the United States vs. Europe

Manufacturers interested in selling medical devices in Europe in addition to the United States need to be familiar with European Union (EU) regulations.

The Medical Device Directives branch of the European Commission (EC) determines how medical devices are regulated in the EU. Although the EC has a similar classification system—Class I, Class IIa, Class IIb, Class III—obtaining marketing approval internationally can be a challenge.

How to Determine Medical Device Classification

So, if you are in the process of creating a medical device, how do you determine whether it is Class I, Class II, or Class III?

The FDA classifies new products by comparing them to medical devices that have already been approved for marketing. By comparing your device’s intended use, indications for use, and technological characteristics with approved products, you can determine the classification.

Find FDA Classification Regulations for Your Device

There are over 1,700 types of medical devices to compare with your new product, grouped into 16 medical specialty panels. These panels broadly cover medical specializations, such as cardiovascular, immunology, or physical medicine.

Your first step is to choose the medical specialty that best describes your product. Then, look through the list of device categories associated with that specialty until you find one that is comparable to your device. Selecting the equivalent regulatory category will give you details such as the regulation number, classification, intended use, and indications for use.

Does the approved product description align with yours? If you think you’ve found a good match, there’s a good chance you’ve discovered your device’s classification.

If you can’t find an equivalent product in the FDA database, all is not lost. Sometimes this indicates that your device is novel enough to require a de novo submission, or in certain rare cases, your device (if life-sustaining) may require a PMA (premarket approval).

Find the FDA Product Classification for Your Device

For further confirmation, you can use the regulation number of the equivalent device category to get more information via the FDA Product Classification Database. Enter the regulation number you found to see a list of product codes. Review these codes and choose the one that best matches your new medical device.

Let in2being Guide You

At in2being, we specialize in helping businesses and individuals navigate the medical device development process. We can guide you through FDA clearance protocols, marketing requirements, and medical device regulation processes. With our holistic approach and experienced leadership, the professionals at in2being are ready to help. Contact us today to learn more.

Let us get you there.

We're ready to lead you from concept, to prototype, to FDA clearance. Let us show you how to push your project forward with a free project analysis. Are you ready to bring your medical device to market?

Contact us to request your free analysis today.