FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR
No more paper. That’s what the FDA requires from the medical device community starting August 14, 2015 with regards to electronic medical device reporting (eMDR). With the draft guidance initially introduced in 2009, and the final rule released in 2014, medical device manufacturers have a little over three months to comply. In the infographic shown below, CDRH submissions overall have dramatically increased through the years. Back in 2006, only 1,575 records were submitted electronically by CDRH to FDA. At year end 2014, electronic submissions to CDRH had reached a record high of 812,443 and are expected to continue to rise going forward.