Defining a Medical Device: What Qualifies and Why It Matters

What is a medical device?

While you were taking a shower, you had an idea for a medical product that could become a pioneer in its field. After some thought, you decided to enter the innovative and adventurous world of the medical-device industry. Then the confusing question arises: “What is a medical device?” If you’re wondering, don’t worry—we’re here to guide you.

Medical devices range from simple contact lenses to prosthetic knee implants and software-embedded instruments such as pacemakers. A device can be the smallest apparatus or a highly complex system.

The big question is not what is a medical device? but who defines what a medical device is?

In the United States, all medical devices are defined and regulated by the Food and Drug Administration (FDA). The Center for Devices and Radiological Health (CDRH) is the branch responsible for medical devices and has full jurisdiction over them.

A medical device is not just a market commodity; it is a state-regulated healthcare product for which the government is accountable to the public. A product becomes a medical device when its features align with the FDA’s definition.

Section 201(h) of the Food, Drug, and Cosmetic Act 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, that is:

• Recognized in the official National Formulary or the United States Pharmacopeia, 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 its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520.

You must define the intended use of your product and its indications. Intended use describes the device’s purpose; indications describe the condition it will diagnose, treat, or prevent. Once these specifications are documented, you can more easily determine whether your product meets the FDA definition of a medical device.

Classification for your product

Your device needs an appropriate FDA classification, which depends on its intended use and indications. Changing the target user market can also affect classification. The higher the class number, the more stringent the regulatory controls required to assure safety and effectiveness.

The FDA assigns devices to one of three classes:

1. Class I—General Controls

These devices are subject to general controls; some may be exempt if the exemption is stated upon classification. General-controls provisions are found in the FD&C Act.

Further reading:

• FDA Medical Device Overview
• WHO: Medical Devices

• 501: Adulterated devices
• 502: Misbranded devices
• 510: Registration of producers of devices
• 516: Banned devices
• 518: Notifications and other remedies
• 519: Records and reports on devices
• 520: General provisions respecting the control of devices intended for human use

2. Class II – general controls plus special controls

Class II medical devices pose moderate risk, so “special controls” are added because general controls alone are insufficient. These controls are tailored to each device.

Here is a list of special controls that are usually device-specific:

• Performance standards
• Post-market surveillance
• Patient registries
• Special labeling requirements
• Premarket data requirements
• Guidelines

3. Class III – general controls and premarket approval (PMA)

According to the FDA, Class III devices are those “intended to support or sustain human life or prevent impairment of human health.”

All such devices require FDA premarket approval, which demands extensive testing and scientific evidence—often including clinical trials—to demonstrate safety.

Products sometimes confused with medical devices

The definition can blur with pharmaceuticals, wellness products, software, or combination products.

Combination products

These unite different product types—drug-device, biologic-drug, biologic-device, or all three. A stand-alone device, by definition, is not a combination product.

Pharmaceuticals

Medicines are chemical entities designed to interact actively with body systems. Devices are mechanical and act only when used as indicated. A drug that fails to work does not thereby become a device.

Health software

Software intended for one or more medical purposes and not part of a hardware device is regulated as a device. Conversely, under §520(o)(1)(B) of the FD&C Act, software that merely supports a healthy lifestyle and is unrelated to disease diagnosis, cure, mitigation, prevention, or treatment is not a device.

Wellness products

Per CDRH guidance, general-wellness products must:

1. Be intended only for general wellness use, and
2. Present low risk to users and others.

Because of their low risk, they are not regulated as medical devices.

So…

“What makes your product a medical device?” boils down to two points:

Further reading: FDA device regulation overview | Classify your device | Software as a medical device

1. Fulfilling the FDA definition of a medical device.
2. Assigning an appropriate classification to your product.

Keep these two prerequisites in mind from the earliest stages of product development.

For questions about audits, processes, or ideation, contact us.

Further reading:

FDA Center for Devices and Radiological Health

Overview of Device Regulatory Controls