April 2007

This is the third article in a series of articles regarding classification of medical devices. As a reminder, the regulations about medical devices are found in the Code of Federal Regulations Title 21, part 800-1050. The device regulations are similar in many ways to the drug regulations, however there are several distinctions. One difference is the definition of a medical device. A medical device is distinguished from a drug in that it cannot react chemically with the body and that it is being promoted or studied for a medical purpose.

With the Medical Device Amendment of 1976, the Food and Drug Administration (FDA) established three classifications for devices. This article will focus on class III devices. Class III devices have insufficient information to determine that they are safe and effective (i.e., any new devices about which there are few or no data are automatically classified as class III). This means that these types of devices need additional regulation in order to ensure safety and effectiveness. Examples of class III devices include implantable orthopedic prostheses (ligament, tendon, hip, knee, finger), eye valve implants (glaucoma implant), and embryoscopes and devices intended for fetal surgery.

Devices that were available on the market prior to the Medical Devices Amendment of 1976 were allowed to remain on the market without demonstrating safety for efficacy with the caveat that, at any time the FDA could ask for a submission of clinical data. Several cases of this type have occurred causing the manufacturer to conduct studies and gather information on their product that is already being marketed.

Before a class III (significant risk) device can undergo clinical investigation, an investigational device exemption (IDE) must be obtained from the (FDA). The application is normally submitted by the sponsor, however Principal Investigators who function in the role of investigator/sponsor may submit the application for review by the FDA. The decision to submit an application to the FDA carries with it a substantial regulatory impact on the sponsor. If the IDE is claimed, a letter from the Center for Devices and Radiologic Health (CDRH) should be obtained referencing the device and the indications and submitted to the Institutional Review Board (IRB) before IRB approval can be granted.

It is important to understand the level of classification particularly as it relates to class III devices. These types of devices are highly regulated and require extensive oversight in order to carefully monitor the safety and efficacy of the device.

*Heath, E. J. (2002). Research Involving a Medical Device. In R. J. Amdur and E. A. Bankert (Eds.), Institutional Review Board Management and Function (pp. 434-440). Sudbury, MA: Jones and Bartlett.