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Table 2 FDA risk classification for medical devices

From: Validation of biomarkers to predict response to immunotherapy in cancer: Volume II — clinical validation and regulatory considerations

FDA Classification Definition
Class I Minimal potential for harm to patients and is subject to the least amount of regulatory controls.
Class II Higher risk to patients and requires greater regulatory controls to provide assurance of safety and efficacy.
Class III Highest risk devices that typically sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. This class has the highest level of regulatory control and therefore must be approved by the FDA before being marketed.