SIMCor. Deliverable 9.6 - Devices approval experience report (BIO, M39)

This report provides an overview of the regulatory dossier (Pre-Submission) that BIOTRONIK submitted to the United States Food and Drug Administration (FDA) to gather feedback on the design of in-silico-clinical-trials for the US regulatory approval of the proprietary PAPS device. To provide insight for both the in-silico community and the specific development aspects of the PAPS device, a set of specific questions were submitted to the FDA. This experience report aims to provide direction for future FDA Pre-Submissions in the field of device-related in-silico-methods and is intended to guide first-time applicants and the in-silico-community. As the value of the FDA’s response is strongly connected to the quality of the questions, this report focuses on the process of identification and refinement of suitable and relevant questions. This report also suggests future strategies to increase the impact of in-silico methods to medical device development, including all endpoints to be covered in an in-silico-clinical trial.