Skip to Main Content

Print | Bookmark | Email | Font Size: + |

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.

spacer

26 Century Blvd Ste ST610, Nashville, TN 37214-3685 © CGS Administrators, LLC. All Rights Reserved