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. Author manuscript; available in PMC: 2013 May 1.
Published in final edited form as: Prog Pediatr Cardiol. 2012 Mar 27;33(2):105–109. doi: 10.1016/j.ppedcard.2012.02.002

Table 1.

FDA Risk-Classification of Medical Devices

Risk to patients Examples
Class I Low Bandage, scalpel
Class II Moderate Cardiac monitor, pulse oximeter, catheter
Class III High VAD, ICD, pacemaker, prosthetic valve

FDA, Food and Drug Administration; VAD, ventricular assist device; ICD, implantable cardiac defibrillator