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 (at) roche.com
Ted Peterson FDA Co-Lead FDA charles.peterson (at) fda.hhs.gov

Project Updates

Provide project updates in this section.

Objectives and Timelines

Objective Timeline
Identify PhUSE process for FDA/Industry communication Mar-2013
Create a CDISC submission roadmap document as a “how to” for submitting medical devices data Jun-2013
Bring members of Device Domain CDISC team on board as necessary Jul-2013
Find a sponsor to collaborate Sep-2013 (or earlier)

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