Difference between revisions of "CDRH Device Pilot"

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m (Objectives and Timelines)
(Project Leads)
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! Name !! Role !! Organization!! E-mail
! Name !! Role !! Organization!! E-mail
|Carey Smoak|| Industry Co-Lead || Roche Diagnostics || carey.smoak@roche.com
|Carey Smoak|| Industry Co-Lead || Roche Diagnostics || [mailto:carey.smoak@roche.com carey.smoak (at) roche.com]
|Ted Peterson|| FDA Co-Lead || FDA || charles.peterson@fda.hhs.gov
|Ted Peterson|| FDA Co-Lead || FDA || [mailto:charles.peterson@fda.hhs.gov charles.peterson (at) fda.hhs.gov]

Latest revision as of 17:44, 8 July 2013

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