# Presentation: 536292

## CDRH Electronic Submissions(CeSub) Turbo 510(k) forIn Vitro Diagnostic Devices

- Sousan S. Altaie, Ph.D.
- Scientific Policy Advisor
- CDRH/OIVD

**OIVD**

## Over View

- Overall Electronic Submission Program in CDRH
- OIVD eSubmission Update
- eReview Module
- Rap Up

**OIVD**

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## Electronic Submissions Overview

**Image 2000 Documentum**

**CDRH Document Control Room:**
**Logs in submission**
**Electronically routes document**

**CeSub - Loader**
**Loads electronic submissions received from eSubmitter, bulk scanning, and unformatted PDF submissions.**
**Version 1.0 released March 2004.**

**CeSub - Submitter**
**Allows manufacturers to complete and submit questionnaires developed by Reviewers.**
**Version 1.0  released March 2004**
**Version 1.11  released March 2006**

**eSub - Designer**
**OIVD, ODE and RAd Health developed questionnaires/templates**
**Version 1.0.1 released January 2004**

**eSub - Reviewer**
**Phase 1 –View the submission Only, released January 2005**
**Phase 2 – Allows users ability to review and comment on submission data electronically, scheduled for release April 2005**

**eRoom**
**Submissions tracking**
**Communications tracking**
**Notes/comments/ annotations**

**Reviewers**

**Reviewers**

**Center Tracking System**
**Submissions tracking**
**Communications tracking**

**Industry**

**OIVD**

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## 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)

**OIVD**

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## 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

**OIVD**

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## eSubmission Enhancements in the Works

- Special 510(k) template
- Bundled 510(k) template

**OIVD**

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## eSubmission Update

- 43 OIVD Turbo 510(k)s so far
-  more than 1⁄2 in 2006 (19 in 04 & 05)
- 74 eLaser Product Report
- No MDRs

**OIVD**

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## eSubmission Next Steps

- Advertise OIVD eSubmission to industry to be use on volunteer basis.
- Expand eSubmissions beyond OIVD.

**OIVD**

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## 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

**OIVD**

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## 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

**OIVD**

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## eSubmitter Registration

**OIVD**

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## eSubmitter- Name Your Submission

**OIVD**

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## eSubmission- select kind of submission

**OIVD**

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## eSubmission- Answer Questions

**OIVD**

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## Business Rules

**OIVD**

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## Business Rules

**OIVD**

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## Help With Product Codes

**OIVD**

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## Missing Data Report

**OIVD**

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## Missing Data Report

**OIVD**

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## Missing Data Report

**OIVD**

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## Missing Data Report

**OIVD**

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## Missing Data Report

**OIVD**

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## Packaging Your Submission

**OIVD**

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## Packaging Your Submission

**OIVD**

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## Submission Through Gateway

**OIVD**

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## Submission Through Gateway

**OIVD**

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## Submission Through Gateway

**OIVD**

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## Submission Through Gateway

**OIVD**

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## Submission Through Gateway

**OIVD**

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## Submission Through Gateway

**OIVD**

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## Submission Through Gateway

**OIVD**

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## CDRH Checks the Document in

**OIVD**

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## CDRH Checks the Document in

**OIVD**

- CDRH eLoader validates and loads the submission into
- eReviewer

## eReviewer Main screen

**OIVD**

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## eReviewer – Main Screen

- Contains four areas
- Favorites
- Working
- Information
- Display

**OIVD**

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## eReviewer Main Screen

**OIVD**

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## The Favorites Area

**OIVD**

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## The Working Area

**OIVD**

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## Maximize Display Area

**OIVD**

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## Collapse Favorites & Working 

**OIVD**

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## Search Functionality Still Visible

**OIVD**

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## Right Click on folder to Print/Save

**OIVD**

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## View Related Submissions 

- View Related Submissions

**OIVD**

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## OIVD Turbo 510(K) eSubmission

**OIVD**

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## Collapse Favorite & Working Area 

**OIVD**

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## View eSubmission Attachments 

**OIVD**

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## Review of the Submission

**OIVD**

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## Commenting on Section

**OIVD**

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## Commenting on Question

**OIVD**

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## Commenting on PDF Attachment

**OIVD**

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## Creating a Document from the Comments

**OIVD**

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## Creating a Document from the Comments

**OIVD**

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## Creating a Document from the Comments

**OIVD**

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## Checking out and Editing Documents

**OIVD**

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## Checking in Edited Documents

**OIVD**

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## Checking in: Version Control

**OIVD**

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## Where Can I get the eSubmission Software?

- Go to OIVD Web Page
- _[http://www.fda.gov/cdrh/oivd/standard](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](http://www.fda.gov/cdrh/oivd/turbo510kcesub1.html)_
- Click _[Download the CeSub eSubmitter Software](http://www.fda.gov/cdrh/ftparea/cdrh/cesub/platforms/Windows/IncludeJvm/jinstall.exe)_ for the software
- Click on _[Download the CeSub eSubmitter Manual](http://www.fda.gov/cdrh/ftparea/cdrh/cesub/updates/manual/eSubmissionUserManual.pdf)_ for the user manual

**OIVD**

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## Slide 58

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## 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
- Go to market faster this time

**OIVD**

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## OIVD

**OIVD**

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