Does the HHS Food Drug and Administration (FDA) approve all medical devices before they can be sold?

Answer

Medical devices are placed into different regulatory classes based upon the degree of control necessary to ensure they are safe and effective. These classes are:

• Exempt - This category covers those Class I medical devices for which no formal FDA review is required. These include simple types of devices that pose little hazard. FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register its establishment and list its products with FDA. Examples include manual stethoscopes and bedpans. Approximately 47% of medical devices are in Class I, and 95 percent of these are exempt from the premarketing clearance regulatory process.

• Premarket Clearance - This category covers Class II devices and a few non-exempt Class I devices that are equivalent to devices already on the U.S. market. FDA review is limited to a determination that the devices are substantially equivalent to other brands of devices legally on the U.S. market in design and medical claims. Examples include powered wheelchairs and some pregnancy kits. Approximately 43% of medical devices fall into this category.

• Premarket Approval - These Class III devices are new types of devices. Class III also includes existing devices being promoted for new uses for which there is insufficient proof of safety and efficacy. The approval process requires testing the device in clinical trials. Data obtained in these trials must be reviewed by FDA and found to support the safety and efficacy of the device when used as labeled. These devices usually sustain or support life, are implanted, or present potential, unreasonable risk of illness or injury. Examples include implantable pacemakers and breast implants. Less than 10% of medical devices fall under this category.

Last Reviewed: 04/23/2008