FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR
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 With the draft guidance initially introduced in 2009, and the final rule released in 2014, medical device manufacturers have a little over three months to comply.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.
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Other FDA FastStats Articles:
- FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR
- FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for the Fiscal Year 2014
- FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies
- FDA FastStats: A Look Back at 2013 Medical Device 483 Observations
- FDA FastStats: Got Safe Beef? New Report Suggests the US Doesn’t
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