AssurX Blog
Straight talk for regulated industries.
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 [...]
Report: Medical Device Approval Still Lags, but FDA is Trying
After years of decline, the speed of FDA device approvals has finally begun to hit the gas pedal a bit, says an interesting new report from the California Healthcare Institute (CHI) an [...]
FDA Applauds GUDID Progress, Eyes Class II Compliance Efforts
The Food and Drug Administration (FDA) reported that there have been over 240 user accounts set up in the agency’s Global Unique Identifier Database (“GUDID”) since the rule’s effectiv [...]
FDA Works to Soothe Industry at Medical Device Cybersecurity Webinar
The FDA will focus more on a device maker's overall approach to ensuring cybersecurity rather than burrowing down and kicking the tires on each individual risk mitigation program, FDAs [...]
FDA Warning Letter Analysis: CAPA, CAPA, and More CAPA!
After a flurry of activity, it's been relatively quiet of late on the FDA warning letter front. But three device makers did get some bad news in recent weeks. FDA's Philadelphia office [...]
