All medical devices sold in the United States are regulated by the U.S. Food and Drug Administration (FDA). More specifically, any medical device manufactured, repackaged, relabeled, and/or imported by any company or firm to sell in the U.S. has to meet FDA regulations.
The FDA states that a Class I medical device, as well as Class II and III, are “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory” that’s recognized as a pharmaceutical or supplement, intended as a diagnoses, cure, or preventive treatment of a disease, with the intention to affect the structure of a human or animal body. The range of medical devices regulated is immense. Such things as pacemakers, cardiovascular stents, respiratory ventilators, surgical trays, breast implants, diagnostic tests (e.g., pregnancy tests, blood glucose tests, etc.) or relatively simple devices such as tongue depressors, patient scales, and elastic bandages need FDA approval.
Regulatory policy for medical devices follows a three-tiered classification system. They are, simply, Class I, II, and III. Though the policy is straightforward enough, there are challenges. The FDA has classified around 1,700 different generic types of devices. These are grouped into 16 medical panels, which are then assigned to one of the three regulatory classes to determine the level of control necessary to assure the safety and effectiveness of the device.
What then, determines if your medical device is Class I, II, or III? The answer is risk. Each medical device is classified by the risks associated with the device. The higher numbered class, the greater the regulatory control, which further defines the regulatory requirements for a general device type. Classification is determined not only by what risk the device poses to the patient and/or the user, but also the intended use of the device along with any specialized indications for its use. For example, a scalpel may have the intended use to cut tissue of a patient, but a manufacturer may have a specialized scalpel specifically designed to make incisions in the cornea.
Here then, are the differences between the different medical device classes:
Class I Medical Devices
A Class I medical device are those devices that have a low to moderate risk to the patient and/or user. Today, 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA. Examples include enema kits, elastic bandages, manual stethoscopes, and bedpans.
Class II Medical Devices
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.
Class III Medical Devices
Class III medical devices are those devices that have a high risk to the patient and/or user. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. They represent 10% of medical devices regulated by the FDA. Examples of Class III devices include implantable pacemakers and breast implants.
We hope this was helpful. BMP Medical is an FDA approved original equipment manufacturer of medical devices. In order to ensure approval, as part of our validation services, we advise and assist clients in helping them understand the distinctions between the different medical device classifications.