Too many medical device companies have the view that electronic medical device reporting (eMDR) won’t be mandated by the FDA anytime soon. That’s a pretty unrealistic view to take these days considering the amount of effort and money that’s being spent at the FDA to modernize their IT facility.  Look at the facts: The FDA’s systems are over 10 years old, and each center within the FDA maintains their own data center that can’t perform cross-departmental queries or has any real analytical tools – a key issue these days for combination products – recently exemplified with deaths related to Heparin coated devices.

Back in September 2008, the FDA announced it planned to spend $2.5 billion to upgrade its technology to better track the safety of drugs, devices and food. The funds will be rewarded to 10 contractors as the agency prepares to transfer their data tracking operations to two new systems.

One of those systems is the FAERS (FDA Adverse Event Reporting System). The FDA says this electronic system will be used for receiving, processing, evaluating and analyzing adverse event reports and other safety information for all FDA-regulated products. The new system, MedWatch Plus, will provide a single point of entry for all FDA regulated products and will combine all the various reporting processes and systems into a single repository. The FDA’s goal is to get away from a center-centric system, and combine it all into a unified adverse event environment.  FAERS will have advanced analytical tools and data mining capability to enable the FDA to standardize the reporting process, analyze thousands of safety reports, and efficiently identify and respond to safety issues.

For medical device companies, the FDA’s plan is to replace the current CDRH’s low volume CeSub (eSubmitter JAVA Applet based program) and implement the Web-based MedWatch Plus Portal. This system will be based on the HL7 ICSR messages that are currently in use by higher volume manufacturers for direct eMDR submissions using the FDA’s AS2 Gateway.

The MedWatch Plus Portal, dubbed the “Rational Questionnaire”, is a joint effort between the FDA and the NIH, and will be a Web-based system for use by consumers, health professionals, investigators, sponsors and other parties for electronic submission of AE reports. This is specifically designed for small device companies with low volume submissions.

The FDA plans to roll out the new FAERS system in phases, with CDRH slated for early 2010. That suggests that the guidance documents for eMDR are due out in the first half of this year, and will most likely require manufacturers to implement eMDR within a year or two.

Think this isn’t important to the FDA? Listen to them talk about it:

“For the first time, we will be able to collect and track safety information from virtually anyone who touches a particular FDA product throughout its life cycle—from manufacturing through initial marketing to its wide-spread use,” explained Dr. Rachel Behrman, FDA Associate Commissioner for Clinical Programs/ Director, Office of Critical Path Programs, the office supporting the effort.  “This will be a key component in an improved, nationwide surveillance system that will strengthen our ability to protect the Nation’s public health.”

For more information about eMDR and the future of the FDA including FAERS, request the 3rd edition of the eMDR eBook here.