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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 for ODE) Electronic PMA submission pilot MDR reports (electronic MedWatch)
5	eSubmission Enhancements Rich Text Editing Spell Check Symbols Notification of Updates Sub-template support Abbreviated 510(k) Special 510(k) 510(k) Supplement-response to deficiency letters
6	eSubmission Enhancements in the Works Special 510(k) template Bundled 510(k) template
7	eSubmission Update 39 OIVD Turbo 510(k)s so far more than ½ in 2006 74 eLaser Product Report No MDRs
8	eSubmission Next Steps Advertise OIVD eSubmission to industry to be use on volunteer basis. Expand eSubmissions beyond OIVD.
9	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
10	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 review submissions received through the Turbo 510(K) eSubmissions
11	eReviewer – Main Screen Contains four areas Favorites Working Information Display
12	eReviewer Main Screen
13	Maximize Display Area
14	Collapse Favorites & Working
15	Search Functionality Still Visible
16	Maximize Information Area
17	Restore Split Screen
18	Right Click on folder to Print/Save
19	View Related Submissions
20	OIVD Turbo 510(K) eSubmission
21	Collapse Favorite & Working Area
22	View eSubmission Attachments
23	Where Can I get the eSubmission Software? Go to OIVD Web Page http://www.fda.gov/cdrh/oivd/standard Under Regulatory Assistance click on CeSub Turbo 510(k) eSubmissions http://www.fda.gov/cdrh/oivd/turbo510kcesub1.html Click Download the CeSub eSubmitter Software for the software Click on Download the CeSub eSubmitter Manual for the user manual
24	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
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