Eletronic Medical Device Reporting Posts

eMDR to Become Mandatory – Ready, Aim… WAIT!

eMDR to Become Mandatory – Ready, Aim… WAIT!

The FDA’s Center for Device and Radiological Health (CDRH)  has had a focused project team engaged in developing, educating, communicating and assisting medical device companies on how to submit Adverse Event reports (MedWatch 3500A) in an electronic format, now known as eMDR (electronic Medical Device Report). In 2005, Indira Konduri, eMDR Project Manager, solicited help from industry to move forward on the testing and confirmation of the eMDR requirements.  The solution leveraged the Health Level 7 standards (HL7) and the outcome was an Individual Case Safety Record (ICSR version 1).  Kudos to the eMDR team during this period when the FDA showed an incredible ability to “listen” to the voice of industry and displayed a willingness to engage in joint discussions on the best way to handle issues. (more…)