PMD13 A Framework for the Creation of Objective Performance Criteria Among Medical Devices: Reflections from Stakeholders

摘要: ObjectivesObjective Performance Criteria (OPC) may serve as a tool to expedite the approval process and continue active surveillance of Class III medical devices. This study aimed to capture reflections from key stakeholders on the creation of OPC and develop a conceptual framework for the creation of OPC with general criteria to be applied to Class III medical devices.MethodsThe conceptual framework was developed through the engagement of key stakeholders and feedback from an advisory committee. A non-probability sampling method using the purposive sampling strategy was employed to identify relevant stakeholders for engagement in semi-structured, open-ended, concept elicitation discussions. A phenomenological approach was implemented to summarize and describe stakeholder perspectives regarding the priorities of, experiences with, roles within, and perceived challenges associated with OPC …