What does Class I, II, and III medical devices mean?
Laura Turnage2021-06-14T05:20:44-05:00According to the FDA website, medical devices are categorized into “one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. The classes are designated according to the level of control necessary to ensure the safety and effectiveness of the device.” Class I devices pose the lowest risk, and Class III devices present the greatest risk.
