Food and Drug Administration Regulation of Medical Devices
The U.S. Food and Drug Administration (FDA) regulates medical devices. This includes the development, marketing, and monitoring of medical devices. Medical devices are classified into three categories. Class I medical devices present little or no risk to health and safety. Class I devices include eye patches, ice bags, scales and organ bags. Class II medical devices present some risk to health and safety and are subject to stricter FDA guidelines. Class II devices include implantable clips and staples for surgery and intravenous containers. Class III medical devices present a potential unreasonable risk of illness or injury. The FDA must approve these devices before they can be sold. Class III devices include some types of internal prostheses and contact lenses.
Premarket Approval of Class III Medical Devices
A manufacturer has to submit an application for FDA approval before selling Class III devices. The applicant must include information about any tests that have been conducted to show whether the device is safe and effective. The components of the device, its design, and its manufacturing process have to be disclosed. Also, the manufacturer must list the intended uses of the device and its proposed labeling. A panel of experts evaluates the information submitted by the manufacturer. This panel writes a report about the device and makes a recommendation to the FDA. The FDA decides whether to accept or reject the manufacturer’s application.
The FDA can also give approval to market a Class III medical device in a streamlined procedure. In this case, the manufacturer must show that the device is substantially equivalent to a Class I or Class II device already on the market or to a Class III device that was on the market before the FDA began regulating medical devices. If the FDA decides that the new device is substantially equivalent and is as safe and effective as the devices already on the market, the FDA will approve the sale of the device.
Investigational Device Exemption
A manufacturer can request an investigational device exemption. If the FDA grants an exemption, the medical device can be used in clinical investigations to determine its safety and effectiveness. However, the device cannot be sold to the general public.
The FDA has adopted manufacturing requirements for all Class II and Class III devices. Most Class I devices are also subject to the FDA’s manufacturing controls. Generally, the manufacturer is required to have a quality assurance program, environmental controls, written cleaning procedures and schedules, and written manufacturing specifications. Inspection of the finished product is also required. Manufacturers must inform the FDA when they receive information that suggests a device has caused or contributed to serious injury or death or has malfunctioned.