Pre-submission Review Process

Due to multiple requests for assistance with Technical Assessments (TA), the MolDX Team is pleased to announce the development of the Pre-Submission Review Process. This new process offers developers the opportunity to receive feedback on dossier materials prior to a TA submission.  Although the Pre-submission Process does NOT affect the requirements or review timeline for a TA, the Team hopes the information obtained through the Pre-submission Review will be used to prepare a comprehensive TA submission package and reduce unsuccessful TA submissions.