Difference between revisions of "CDRH Device Pilot"

From PHUSE Wiki
Jump to: navigation, search
(Created page with "{{RightTOC}} = 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...")
 
m (Objectives and Timelines)
Line 24: Line 24:
 
!Objective!!Timeline
 
!Objective!!Timeline
 
|-
 
|-
|Define Scope with CDRH||TBD
+
|Identify PhUSE process for FDA/Industry communication||Mar-2013
 
|-
 
|-
|Perform Pilot||TBD
+
|Create a CDISC submission roadmap document as a “how to” for submitting medical devices data||Jun-2013
 
|-
 
|-
|Evaluate Pilot||TBD
+
|Bring members of Device Domain CDISC team on board as necessary||Jul-2013
 +
|-
 +
|Find a sponsor to collaborate||Sep-2013 (or earlier)
 
|-
 
|-
 
|}
 
|}

Revision as of 13:08, 13 March 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@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
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