SOFTWARE >>
and advises whether each report the following fourprocedures.
loaded properly into the CDRH de- MONTH eMDRs FILED Pick a Number. If the volume of
vice report database. The absence of August 2007 3 reports is expected to be low, the
an XML-formatted acknowledgment company should use FDA’s CeSub
makes it difficult for the report sender September 2007 44 submissions platform. Otherwise, the
to determine immediately whether its October 2007 36 company should prepare to use a full-
eMDR report was accepted or wheth- featured eMDR system.
er it needs to be resubmitted. CDRH November 2007 3 Pick a Database Platform. Deter-
says it is actively developing a standard December 2007 21 mine whether the company already
XML-formatted acknowledgment for has a software platform suitable for
the eMDRs that it receives. January 2008 28 storing and retrieving complaint in-
As knowledge of FDA’s eMDR sys- tem proliferates, and as clarity emerg- February 2008 35 formation. If not, design one in-house or select a commercially available
es on the challenge of acknowledg- March 2008 86 complaint management system.
ments, a higher level of adoption may be achieved. But driving the majority April 2008 570 Pick a Reporting Platform. Deter- mine whether the company already
of device firms to adopt the eMDR sys- May 2008 626 has a software platform that can gen-
tem will likely take a truly compelling event. Almost certainly, that event will Total 1452 erate properly formatted eMDR out- put. In some cases, software for this
occur when CDRH releases its long- Table II. Electronic medical device reports purpose may be integrated with com-
expected rules requiring that manufac- filed with CDRH from August 2007 through mercially available complaint man-
turers implement eMDR systems over May 2008. Source: FDA. agement systems. If no such system is
paper 3500As. available, design one in-house or choose
a commercially available eMDR reporting platform.
Pick a Transmitter. Choose an EDI transmission provider
or use in-house facilities.
FDA is available to help with every phase of develop-
Planning for the Future
Preparing to implement an eMDR system is not complex.
Organizations can determine a course of action by doing
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