What is Considered a Medical Device?

What is a medical device?

While you were taking a shower, you had this amazing idea of a medical product that could potentially become a pioneer of its own kind. After consideration, you’ve decided to jump into the innovative and adventurous world of the medical device industry. But then, the confusing question will arise — “What is a medical device?”. If you find yourself wondering about this, there’s no need to worry. We are here to guide you on this journey of medical devices.

Medical devices could range from simple contact lenses to prosthetic knee implants and medical devices with embedded software like pacemakers. A medical device could be the smallest medical apparatus to the most complex.

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

In the USA, all medical devices are defined and regulated by the food and drug administration (FDA). The center for devices and radiological health (CDRH) is the specific branch intended for medical devices. It has complete jurisdiction over it.

A medical device is not only a commodity in the market but is also a state-regulated healthcare product, to which the state’s accountability towards its people. What makes a product a medical device is if its features become congruent to that of the definition stated under the stipulations of the FDA.

A medical device is quite simply and plainly defined under Section 201(h) of the Food, Drug, and Cosmetic Act 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 a 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.

You must define the intended use of your product and its indications. Its intended use includes the purpose of your device while its indications describe the condition that it aims to treat, diagnose, or prevent. Once you have written down all these specifications, it will be easier to determine if your product meets the FDA’s definition of a medical device or not.

Classification for your product

Your medical device should have a proper medical device classification. This classification should follow FDA guidelines as well. Classification also highly depends on the product’s intent and its indications for use. Changing your product’s user market affects the classification of your product as well. The higher the class number, the more stringent regulatory measures are required to ensure the safety and effectiveness of your device.

The FDA has the following classifications for a medical device:

  1. Class I- General Controls

This can be divided into devices that require general controls and those that have a special exemption. The exemption should be stated upon classification.

General controls can be found in the following sections of the FD&C Act:

  • 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 and special controls

The moderate risk that comes with Class II medical devices requires what is known as “special controls” since general controls alone are not enough. These special controls are relative to the context of each device.

Here’s 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 medical devices are those that are “intended to be used in supporting or sustaining human life or preventing impairment of human health.”

All devices that fall under this category are subject to what is known as premarket approval by the FDA. Premarket approval requires extensive experimental procedures and scientific pieces of evidence. It can come in the form of a clinical trial, to prove that the device will be safe for the users.

Confusing products with medical devices

The definition could be confusing at times with other products such as pharmaceuticals, general wellness products, software products, or combination products

Mixed products

Combination products are a mix of products that have are different by nature. For instance, a combination product is a mixture of a drug and a device, a biologic and a drug, a biologic and a device, or a mix of all three together. Therefore, by definition, a stand-alone medical device cannot be a combination product.

Pharmaceuticals

Pharmaceuticals are medicines and are chemical in nature designed to engage and actively interact with the body’s system. Medical devices are by nature mechanical and work only if they are used correctly based on their indications for use. Pharmaceuticals either work or they don’t. However, Pharmaceutical products that do not work also do not qualify them as a medical device.

Health Software

Medical device software is defined as a “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” On the other hand, Section 520(o)(1)(B) of the FD&C (Food, Drug & Cosmetics) Act, states that “any other software intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition is not a device under section 201(h) of the FD&C Act.”

Wellness products

According to CDRH, general wellness must meet the following:

  1. Are intended for only general wellness use, as defined in this guidance, and
  2. Present a low risk to the safety of users and other persons.

Because of their generally low-risk nature, they need not be classified and regulated as a medical device under the FDA.

So…

“What makes your products a Medical device?” can be shortened in two things:

  1. Fulfilling the definition of a Medical Device according to the FDA.
  2. Having an appropriate classification for your product.

These two are the prerequisites that you need to keep in mind as early as possible in the product development process of your potential medical device.

For more inquiries regarding audits, processes, ideation, and more don’t hesitate in contacting us.


References:

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device#:~:text=Class%20I%20includes%20devices%20with,I%2C%20II%2C%20and%20III.

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device#:~:text=Class%20I%20includes%20devices%20with,I%2C%20II%2C%20and%20III.

https://www.fda.gov/medical-devices/digital-health/software-medical-device-samd

https://www.fda.gov/media/90652/download

https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health

https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls#gen

https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber

https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder

https://www.fda.gov/about-fda/fda-organization/center-veterinary-medicine

https://www.fda.gov/about-fda/fda-organization/center-tobacco-products