CDRH Device Pilot

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Project Overview

With the recent development of new SDTM-based device domains, industry and CDRH would like to conduct a Pilot to evaluate the use of the domains for submission.

Project Leads

Name Role Organization E-mail
Carey Smoak Industry Co-Lead Roche Diagnostics carey.smoak@roche.com
Ted Peterson FDA Co-Lead FDA charles.peterson@fda.hhs.gov

Project Updates

Provide project updates in this section.

Objectives and Timelines

Objective Timeline
Define Scope with CDRH TBD
Perform Pilot TBD
Evaluate Pilot TBD

Project Content and Activities

This section can document project activities or serve as a jumping off point to other pages in the project.

Meeting Minutes


Archived Content