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1	CDRH Electronic Submissions (CeSub) Turbo 510(k) for In Vitro Diagnostic Devices Sousan S. Altaie, Ph.D. Scientific Policy Advisor CDRH/OIVD
2	Over View Overall Electronic Submission Program in CDRH OIVD eSubmission Update eReview Module Rap Up
3	Electronic Submissions Overview
4	Other Electronic Submissions Pilots in the works Electronic 510(k) submission pilot (table of contents) Electronic PMA submission pilot
5	eSubmission Enhancements Rich Text Editing Spell Check Notification of Updates Sub-template support
6	eSubmission Update 5 OIVD Turbo 510ks (five in the pipelines) 28 eLaser Product Reports
7	eSubmission Next Steps Finalize submission templates changes. Send out new software to eSubmission participants in April, 2005. Make OIVD eSubmission available to industry on a volunteer basis. Expand eSubmissions beyond OIVD.
8	Image 2000 is now eReviewer Basic functionality is the same Interface has been modified to allow review staff more screen real estate Added a Working Area to provide a collaborative space for users to review and link additional information to the submission Users can now minimize and maximize Information, Display, and the Favorites area
9	Image 2000 is now eReviewer (Con.) Search functionality is now available from main screen Search allows users the ability to choose between conducting a search within a submission folder or within the entire Image 2000 repository OIVD users are now able to view submissions received through the Turbo 510(K) eSubmissions Pilot
10	eReviewer – Main Screen Contains four areas Favorites Working Information Display
11	eReviewer Main Screen
12	Maximize Display Area
13	Collapse Favorites & Working
14	Search Functionality Still Visible
15	Maximize Information Area
16	Restore Split Screen
17	Right Click on folder to Print/Save
18	View Related Submissions
19	OIVD Turbo 510(K) eSubmission
20	Collapse Favorite & Working Area
21	View eSubmission Attachments
22	What Is In It For Me As A Volunteer? Have an input in what could become a standard program Being trained in using the tool first Given priority in review this time Go to market faster this time
23	Demo