What Is Class-II Medical Equipment?

Classification of medical devices is a system created by the United States Food and Drug Administration (FDA) to determine the level of control necessary to ensure the safety and effectiveness of such devices. In other words, classification designates, among other things, the risk the device poses to the patient and/or user. Class II is mid-level risk; Class I indicates the lowest risk and Class III indicates greatest risk.

Background

• Class II medical devices are considered mid-level risk.

  The FDA has established classifications for approximately 1,700 generic types of devices and grouped them into 16 medical specialties referred to as panels. Classification depends on intended use for the device in relation to the risk that use poses. For example, a scalpel’s intended use is to cut tissue.

Other Factors

• In addition to indicating levels of risk, classification determines the type of premarketing and submission/application required for FDA approval. Items identified as Class I or II, if also not exempt, require a 510K for marketing. This is a requirement issued in section 510(k) of the Food, Drug and Cosmetic Act requiring manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. Devices that are exempt from this requirement are not exempt from general controls, i.e., the least-regulatory controls required by the FDA. These include registration, medical device listing with the FDA, manufacturing in accordance with "good manufacturing practices," labeling in accordance with labeling regulations and medical-device reporting of adverse events

Determining Classification

• Every device is issued a regulation number that determines classification and exemptions. You can find the regulation number by going to the classification database offered by the FDA (accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm) and searching for the device name. You can also find the regulation number by going to the listing for the device panel (medical specialty) to which the device belongs and identifying it and the regulation. Information on device panels is available at fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/UCM051530.

Class II

• While Class I devices require the least stringent regulatory control due to their minimal potential harm, Class II devices must have more than the simple general controls to ensure safety and effectiveness. They must also comply with "special controls": special labeling requirements; mandatory performance standards, both international and U.S.; postmarket surveillance; and FDA medical-device specific guidance. Examples of Class II medical devices include powered wheelchairs, infusion pumps and surgical drapes.

Reclassification

• The FDA has created a reclassification process that can adjust classification if and when experience and knowledge of devices alter their risk level/uses. The FDA can change a device’s classification by regulation of its own accord or in response to outside petition. In the event a manufacturer or other party wishes to lower a classification, that party must convince the FDA that the less-stringent class requirements will be sufficient to provide reasonable assurance of safety and effectiveness, according to the FDA.

  If the FDA agrees a change is appropriate, it publishes a proposed rule to reclassify the device in the Federal Register--which includes the scientific justification for the change--offering a period for comment. A final rule is published after that period in the Federal Register.