ment. The agency encourages manufacturers and other
reporters to use a two-pronged development effort. In
this approach, one group prepares formats for the eMDR
output files, while the other works on setting up EDI
communications.
Ready, Set, Test
After preparations for storing, reporting, and transmitting eMDRs have been completed—and prior to submitting
any actual adverse-event reports—FDA requires users to
set up a test account. This account is used for testing all
phases of the eMDR cycle, including XML file validation,
transmission verification, and posttransmission processing
of acknowledgments. Instructions for setting up a test account can be downloaded from FDA’s ESG Web site.
Each user of the ESG must submit a nonrepudiation
agreement letter. This letter includes the user’s actual signature, and acknowledges that a digital certificate may be
used as the submitter’s electronic signature.
All eMDR data that are transmitted to FDA must be
encrypted. Encryption is accomplished through the use of
the digital certificate assigned to each user. Thus, digital
certificates are used to encrypt data, and they also function
as electronic signatures for their assigned users. Digital
certificates may be valid for varying durations, but FDA
only accepts two-year certificates.
Once the test account has been created, the ESG permits
transmission of test files. A reply e-mail detailing the status
of the testing is returned after each test. When testing has
been completed, the user can begin production and transmission of live eMDRs.
Conclusion
Although CDRH continues to accept paper reports, it is
no longer accepting MDRs on CD or DVD without special
approval. Once the eMDR acknowledgment challenge has
been resolved, and all return messages are in XML format,
the countdown to mandatory eMDR submission will begin.
For medtech engineers, understanding an e-reporting strategy
now will help to avoid a compliance crunch later.
References
1. Report of the Postmarket Transformation Leadership Team:
Strengthening FDA’s Postmarket Program for Medical Devices
(Rockville, MD: CDRH, FDA, 2006); available from Internet:
www.fda.gov/cdrh/postmarket/mdpi-report-1106.html.
2. eMDR: Electronic Medical Device Reporting, Health Level Seven
(HL7) Individual Case Safety Reporting Files [downloadable
zipped files] (Rockville, MD: CDRH, FDA, 2007 [accessed 8
July 2008]); available from Internet: www.fda.gov/cdrh/emdr/
eMDRHL7files.zip.
3. FDA Electronic Submissions Gateway (ESG) [online] (Rockville,
MD: Center for Devices and Radiological Health, FDA, 2007 [ac-
cessed 8 July 2008]); available from Internet: www.fda.gov/esg. ■
