According to the FDA a medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis (IVD) of disease and other medical conditions such as pregnancy.

FDA has a classification system for medical devices that is made primarily on the level of risk to users/patients and, therefore, the level of FDA oversight needed to ensure that the device is safe and effective as labeled. Generally, but not always, this corresponds to logical risk evaluations.

Class Controls Products

  • Class I crutches, band aids
  • Class II wheelchairs, tampons
  • Class III heart valves (known to present hazards requiring clinical demonstration of safety and effectiveness) - OR - not enough known about safety or effectiveness to assign to Class I or II

Frequently Asked Questions


Are medical devices used as an interim treatment or as a long term strategy to address an illness or a disease?

Medical devices can be used for either application; an example of an interim treatment application is the use of a ventricular assist device to aid a weakened or diseased heart until a suitable heart can be procured for a heart transplant.

An example of a long term treatment strategy would be a heart valve implant.


What are the potential future applications of medical devices?

As regenerative medicine technology matures, scientists and clinicians are optimistic that support systems for failing organs will become available.  As an example, there are laboratory studies to develop a bioartificial liver that could support a patient with liver failure until the liver regenerates, or until a liver transplant can be performed.


Can medical devices be used in conjunction with other forms of regenerative medicine?

Generally scientists and clinicians categorize regenerative medicine in one of three categories: medical devices, cell-based therapy, and tissue engineering. Each of these areas can be complimentary in the repair of damaged or diseased tissue.

One example of a medical device is a ventricular assist device (VAD) -- a battery powered pump that can be implanted to assist a sick heart. In most cases, for this type of situation, the ultimate therapy is a heart transplant. The VAD serves as a bridge to a transplant. However, clinicians have used VAD's in conjunction with cellular therapy or other medications to help a sick heart heal. In those instances, the VAD assists in the blood pumping and gives the heart a rest, while the other therapy helps to correct the defective condition.

It should be noted that certain tissue engineering products are classified by the FDA as a medical device. As an example, a bioengineered material discovered 20 years ago is now playing a crucial role in treating conditions ranging from incontinence to burns. This discovery has evolved into a significant advance in tissue engineering, laying the groundwork for a host of new medical treatments. The extracellular matrix (ECM) has been used to create a biologic scaffold for tissue repair. The ECM consists of structural and functional proteins including many types of collagen, growth factors, and support molecules. Additionally, the ECM not only serves as nature's starting point for tissue healing, but also supplies the foundation for wound repair. For instance, ECM-associated molecules generated during wound healing have potent functions, helping to resist infection and recruiting tissue-building molecules for the site of injury.

Physicians rely on the material for reconstructing ligaments to treating incontinence. Today, ECM-based products are most commonly used to help the body close hard-to-heal wounds such as second-degree burns, chronic pressure ulcers, diabetic skin ulcers, and deep skin lacerations. The ECM fosters a molecular environment that can speed up the body's own healing process.