AssurX Blog
Straight talk for regulated industries.
FDA Update on UDI Implementation for Registered Medical Device Establishments
In case you missed it, the FDA issued this update on UDI yesterday: Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III dev [...]
Got Safe Beef? New Report Suggests the US Doesn’t
FSMA: Got Safe Beef? New Report Suggests the US Doesn't: The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Bas [...]
FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies
FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies: In our latest infographic analysis, today's post highlights medical device warning l [...]
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations: As we approach the end of 2014, we will take a look back at FDA's stats on various topics sourced from their Case fo [...]
FDA’s Local Offices Flex Regulatory Muscle
In our latest round-up, it was the District Offices turn to chime in on medical device company alleged shortcomings. As expected, the FDA is shifting more and more of its regulatory fo [...]
Are You Ready for 21st Century eMDR Submissions?
Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might [...]
