Understanding Medical Device Classifications
According to the U.S. Food and Drug Administration, all medical devices sold, manufactured, repackaged, relabeled, or imported to the U.S. to sell must meet all FDA regulations. The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory that is recognized as a pharmaceutical or supplement, intended as a diagnosis, cure, or preventive treatment of a disease.” This wide-sweeping definition includes everything from pacemakers, cardiovascular stents, respiratory ventilators surgical trays, breast implants, diagnostic tests (i.e., pregnancy tests, blood glucose tests, etc.), tongue depressors, patient scales, and elastic bandages. All these things and many more all require FDA approval prior to being used in a medical setting.
Under the umbrella of FDA classification, there are three tiers. These tiers are simply called Class I, Class II, and Class III. The classification system is intended to determine the level of oversight and control necessary to ensure patient safety and the effectiveness of the device. The FDA has classified around 1,700 different generic types of devices, with these types being grouped into sixteen different medical panels. These panels are then assigned to one of the three classification classes.
The main thing that distinguishes each class from another is the amount of risk involved. The higher the numbered class, the greater the regulator control required by the FDA. This involves more than the risk posed to the patient and/or user of the device, but it also considers the intended use, along with any specialized implementation for its use.
Here is a deeper look into the different classifications as established by the FDA.
Class I includes all instruments and devices that have a low to moderate risk level to the patient and/or user. Currently, 47% of medical instruments and devices fall into this category, with 95% of those being exempt from the regulatory process. Those items that fall into a generic category of exempted items, do not need a premarket notification or FDA clearance before marketing their device in the U.S. However, the item is required to be registered with the FDA.
All items that pose a moderate to high risk to either the patient or user fall into the Class II classification. Within this classification are 43% of all medical instruments. A majority of medical instruments are considered to be Class II. Within this classification, you will find items such as powered wheelchairs and some pregnancy test kits.
Class III is comprised of all devices that pose a high risk to either the patient or the user. These items are generally used to sustain or support life, are implanted, or present a potential unreasonable risk of illness or injury. Approximately 10% of all medical instruments are classified as Class III. Examples of Class III devices include implantable pacemakers and breast implants.
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