Determination of patient contact duration for medical device classification: Impact for repeat-use devices

Medical device development should include risk-based considerations that evaluate product functionality, efficacy and safety. From prototype design to final device submission, development strategy should lie at the intersection of engineering principles, biological safety and regulatory pathway. The biocompatibility testing and regulatory scrutiny on a medical device is highly dependent on its intended use in clinical application. Medical devices are classified in the biocompatibility testing matrix based on patient contact and patient contact duration.