What Will You Learn? What Will You Learn?: April 28, 2011

4/26/2011
Complaints, MDRs, Reports of Removals

& Corrections, and Recalls
April 28, 2011
4/26/2011 Copyrighted material by Pilgrim Software Inc. All Rights Reserved. This document contains confidential and/or proprietary information. Do not distribute 1
What will you learn?
• why move to eMDR’s

• what is eMDR
• the eMDR system overview and process
• what options do I have (low \ high volume)
• steps for approval
• lessons learned
• where do I go to learn more
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4/26/2011
MDR’s Reported
350,000
300,000
250,000
200,000 2006
2008
150,000 2009
2010
100,000
50,000
0
MDR's Reported by year
• Focus on Mandatory Reports • Number of MDR’s are increasing
• 2010 numbers based on Kathleen Cummings Food and Drug Law Webinar
The way it is for Manufacturers
Mandatory MedWatch fillable PDF

Form or solution generated
Manufacturer
Manufacturer’s mail, overnight, Burn
CD’s and express MDR’s to the FDA.
Did the FDA get Do they need

It in time? something else?
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The way it is for the FDA
Attachments
Mandatory MedWatch
MAUDE
FDA receives report and has

Summary Reports
contractors type Data into
MAUDE database
FDA eMDR Goals
• Eliminate human error for data entry

• Reduce non-value added costs
• Receive accurate and timely information
• Analyze and Trend on elements in Adverse
Event Reports
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Federal Register August 21,2009
• Rules
– Proposed Rule
• Medical Device Reporting: Electronic Submission
Requirements , 42203–42217 [E9–19683]
• http://edocket.access.gpo.gov/2009/pdf/E9-19683.pdf
• Notices
– Draft Guidance for Industry, User Facilities, and Food and
Drug Administration Staff: eMDR Electronic Medical Device
Reporting; Availability , 42310 [E9–19681]
• http://edocket.access.gpo.gov/2009/pdf/E9-19681.pdf
What is eMDR?
eMDR stands for electronic Medical Device Reporting.

The eMDR project allows for electronic receipt and
processing of medical device adverse event reports to
CDRH, through the following processes:
• 1. ) Build &Transform Data: generate MedWatch data file (xml)

using HL7, ICSR Release 1message format that is mapped to the
3500A.
• 2.) Transmit the Information: The file will be transmitted

electronically to the FDA’s Electronic Gateway called (FDA ESG)
where it will automatically “load” the MedWatch file into the
FDA’s databases.
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What reports are part of eMDR?
• Manufacturer’s Mandatory MedWatch Report

• Importer and User Facility Report MedWatch Report
• MedWatch Reports with attachments as part of the
electronic file
• Follow-Up\Supplemental MedWatch Reports
• Batch reporting on the above types of MedWatch
Reports
• CDRH eMDR Phase 1 does not include:

• Alternative Summary Reporting
Definitions
Definitions to navigate through eMDR
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Definitions to navigate eMDR
FDA ESG (FDA Electronic Submission Gateway)

• FDA Electronic Submissions Gateway is an FDA agency-
wide entry point for all electronic submissions; it is an
electronic portal that routes submissions to the
appropriate FDA Center. This is the single point of entry
for the receipt and processing of all electronic
submissions in a highly secure environment that
complies with secure messaging standards.
• CHDC (Contractor Hosted Data Center) is a new data
center for the FDA ESG
Digital Certificate
• This is a two-part electronic key, that when matched
together defines who you are as the company or
submitter. You have to have a digital certificate if you
submit through Web Trader or through your B2B
mechanism.
– Must be X.509 V3 compliant
– List of vendors at the FDA ESG website
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Letter of Non-Repudiation
– A letter of Non-Repudiation Agreement must be
submitted to the FDA. The non-repudiation
agreement allows the FDA to receive electronically
signed submissions in compliance with 21 Code of
Federal Regulations (CFR) Part 11.100.
– Sample letters are on the FDA ESG website.
FDA eSubmitter
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Web Trader
• Log into Web Trader

• Select the FDA center: CDRH
• Browse to select your eSub zipped file
• Select Adverse Events
• Browse to select your half of the digital
Certificate, private key
15
MAUDE
• Manufacturer and User Facility Device Experience
Database.
• MedWatch reports are submitted to the MAUDE
database for analysis by the FDA.
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eMDR Process – Step 1
• Build & Transform the Data: enter your MedWatch information into an
application and generate MedWatch data file.
• What the application has to use?
• HL7 standard (ANSI accredited standards organization)
• ICSR Release 1– Individual Case Safety Report messaging format, mapped to
the 3500A
• Utilizing codes defined by National Cancer Institute (NCI) and unique FDA
codes
1) Enter (build) your MedWatch information
2) Transform data into an xml file
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4/26/2011
eMDR Process – Step 2
• Transmit the Information: The file will be transmitted electronically to the

FDA’s Electronic Gateway called (FDA ESG) where it will automatically “load”
the MedWatch file into the FDA’s database.
• What you have to use?
• Connector to FDA ESG Portal
• AS2 protocol
• NOT EMAIL
FDA ESG Overview
Inbound Submission (1)
Acknowledgement #1 (2) Centers
eMDR file
FDA Gateway
Industry Server
Partners
Acknowledgement #2 (4) Transfer Submission (3)
CDRH Load to eMDR (5)

ACK’s
Acknowledgement #3 (6)
1. Manufacturer sends eMDR single or batch files to FDA Electronic Submissions Gateway (ESG) using either Web Trader
or AS2 compatible transport mechanism.
2. FDA ESG server receives an inbound submission, checks digital certificate for authentication and sends
Acknowledgment 1 to the submitter. This confirms that the submission was successfully received by the FDA ESG.
3. The submission is automatically transferred to the appropriate FDA Center, specifically CDRH.
4. Acknowledgment 2 is sent by FDA ESG to the submitter to indicate that the submission has been sent to CDRH.
5. The Center validates and processes the submission.
6. Acknowledgment 3 is sent to the submitter to indicate if submission is successfully loaded into the Adverse Event
database or note any errors that occurred during validation and loading.
* Source CDRH Implementation Guide for eMDR

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Acknowledgment 1 Acknowledgement Examples
E
S
G
Acknowledgment 2
E
S
G
Acknowledgment 3
C
D
R
H
How to build/transform your eMDR file?
– Low Volume: FDA eSubmitter – free downloadable software
Step 1
FDA eSubmitter XML file
3500A MedWatch in
COTS
eMDR submission format
ICSR Release 1 message
Data “transformed”
- High Volume: a) Commercial Off the Shelf Software b) Internally built solutions
c) middleware solutions that “Transform” data.
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Step 1 Decision Chart
Use Paper Based

NO Do you have Complaint Management
system as source System Software Solution ?
for eSubmitter
entry
YES
Use Software NO Does your System allow you generate a

system as source MedWatch report for you?
for eSubmitter
entry
YES
Does your System have ability to transform your YES Upgrade, separate
data into eMDR HL7 compliant file? install, etc
NO
Use Software
system as source
NO Does your IT group have ability to transform your YES
Middleware, etc
for eSubmitter data into an eMDR HL7 compliant file?
entry
How to transmit the eMDR file?
– Low Volume (manual solution)

• Web Trader – free connector for electronic file submission to the FDA ESG
- High Volume (automated solution)

Deploy an AS2 compatible transport mechanism that can connect to the
FDA ESG (i.e., B2B)
Step 2
Web Trader
Step 1
XML file
- OR -
3500A MedWatch in FDA ESG Gateway

eMDR submission format
B2B
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Step 2 Decision Chart

WebTrader (AS2) B2B (AS2)
YES Leverage existing

Does your company have a B2B in place?
B2B
NO
Do you have a sister division that uses a B2B?
Utilize free FDA
Currently submitting electronically to the FDA?
connector for NO Purchase or
one at a time Do you have resources to maintain a B2B? YES Leverage existing
submissions Do you have skill set to implement a B2B? B2B and
resources
Can you justify with your submission volume
Purchasing a B2B?
Options Build/Transform/Transmit
eSubmitter Step 1 Options Step 2 Options
HL7/ICSR xml file WebTrader (AS2) ACK

1
Application’s transform data
COTS
FDA
ESG
Write transformation code HL7/ICSR xml file B2B (AS2)
COTS
Custom
ACK
2
Configure transformation code

Middleware HL7/ICSR xml file CDRH/
COTS MAUDE
ACK
Custom
3
BUILD
DATA TRANSFORM TRANSMIT FDA
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4/26/2011
Attachments
Generated
HL7 xml
Attachments (if any)
For MDR reporting the parser

that accepts the submissions
only understands two file types:
.pdf and .zip.
Submitting other types will
cause the submission’s pdf
YourFinalESubmission.zip
form or the attachments not
For eSubmitter Files
to be entered Into FDA’s
archiving system.
Steps to FDA ESG Approval
• Go to the FDA ESG website

• Follow the FDA ESG Implementation steps in the User guide
• Initially
• Determine how you are going to do your eMDR
submissions (Web Trader\AS2)
• Submit a Letter of Non-repudiation (examples at website)
• Obtain Digital certificate (see FDA ESG website)
• Register as a Trading Partner
• Send an email and then register on-line
• Signup for the test environment (Web Trader or AS2)
• Initial testing through Web Trader or your AS2 connector
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Steps to CDRH eMDR Approval
• Request your submission testing to the eMDR team

eMDR@fda.hhs.gov
• Below are six types of reports that are requested for testing. If a
particular report does not apply to your situation, please discuss
with an eMDR team
• Initial 3500A
• Initial 3500A with an attachment
• Initial 3500A followed by a supplemental 3500A (supplemental
should be submitted after initial is loaded successfully)
• Initial 3500A with section F filled out (section F is used to
provide information from user facility or importer source
report)
• Initial 3500A and source report(s) as attachments
• Batch submission that includes more than one 3500A
Lessons Learned
• Attachments must be zipped and submitted within the xml file (except for PDF files)
• All testing has to be done with valid registration numbers for manufacturing
numbering, Importer or User Facility numbering in Section F
• Paradigm shift
Moving away from the physical form to “information”
Putting all information into the discrete data sections instead of H10/11
• Some manufacturers were struggling with internal systems to get digital certificates
for testing using the Web Trader
• Manufacturer’s IT and Functional groups have to work together to work through
the testing and plans for moving to production
• Start with the Web Trader for your initial rounds of testing and familiarity with the
entire process
• If using AS2 still utilize Web Trader as a backup
• Special characters can cause problems with generation of an xml file and the
validation as it goes to MAUDE
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eMDR Website
• Reporters should subscribe at eMDR Home Page for updates!
eMDR Contact Information
• Low Volume - eSubmitter “download and installation”

– http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm108165.htm
• High Volume – HL7 Requirements

– http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Postmar
ketRequirements/ReportingAdverseEvents/ucm127951.htm
• Email Contact eMDR Project Team

– eMDR@fda.hhs.gov
• FDA Electronic Submission Gateway (FDA ESG)

– http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
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4/26/2011
Thank You and Questions
17

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4/26/2011

Complaints, MDRs, Reports of Removals

What will you learn?

• why move to eMDR’s

• Focus on Mandatory Reports • Number of MDR’s are increasing

The way it is for Manufacturers

Mandatory MedWatch fillable PDF

Did the FDA get Do they need

The way it is for the FDA

FDA receives report and has

FDA eMDR Goals

• Eliminate human error for data entry

Federal Register August 21,2009

eMDR stands for electronic Medical Device Reporting.

• 1. ) Build &Transform Data: generate MedWatch data file (xml)

• 2.) Transmit the Information: The file will be transmitted

What reports are part of eMDR?

• Manufacturer’s Mandatory MedWatch Report

• CDRH eMDR Phase 1 does not include:

Definitions to navigate through eMDR

Definitions to navigate eMDR

FDA ESG (FDA Electronic Submission Gateway)

Definitions to navigate eMDR

Definitions to navigate eMDR

• Log into Web Trader

Definitions to navigate eMDR

eMDR Process – Step 1

2) Transform data into an xml file

eMDR Process – Step 2

• Transmit the Information: The file will be transmitted electronically to the

FDA ESG Overview

Inbound Submission (1)

Acknowledgement #1 (2) Centers

CDRH Load to eMDR (5)

* Source CDRH Implementation Guide for eMDR

Acknowledgment 1 Acknowledgement Examples

How to build/transform your eMDR file?

– Low Volume: FDA eSubmitter – free downloadable software

FDA eSubmitter XML file

Step 1 Decision Chart

Use Paper Based

Use Software NO Does your System allow you generate a

How to transmit the eMDR file?

– Low Volume (manual solution)

- High Volume (automated solution)

3500A MedWatch in FDA ESG Gateway

Step 2 Decision Chart

YES Leverage existing

HL7/ICSR xml file WebTrader (AS2) ACK

Write transformation code HL7/ICSR xml file B2B (AS2)

Configure transformation code

For MDR reporting the parser

Steps to FDA ESG Approval

• Go to the FDA ESG website

Steps to CDRH eMDR Approval

• Request your submission testing to the eMDR team

• Reporters should subscribe at eMDR Home Page for updates!

eMDR Contact Information

• Low Volume - eSubmitter “download and installation”

• High Volume – HL7 Requirements

• Email Contact eMDR Project Team

• FDA Electronic Submission Gateway (FDA ESG)