CDRH Device Pilot
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.
|Carey Smoak||Industry Co-Lead||Roche Diagnostics||carey.smoak (at) roche.com|
|Ted Peterson||FDA Co-Lead||FDA||charles.peterson (at) fda.hhs.gov|
Provide project updates in this section.
Objectives and Timelines
|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.