August 26, 2015 - Revised: 10.05.15
Pre-submission Review Process (CM00013)
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.
To request a Pre-submission Review, please follow the steps outlined in the instruction document, complete the form, collect appropriate reference and study material per the instructions and submit your request.
- Pre-submission Review Instructions– Step by step instruction for developers to request a pre-submission meeting and the material required
- Pre-submission Guidance Form – Required form must be completed and submitted with a pre-submission request