AssurX Blog
Straight talk for regulated industries.
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 [...]
Medical Device Cybersecurity Risks Are The Wrong Kind of Halloween Fright
Well, Halloween is approaching boys and girls. And while it's fun to don a Dracula (or Miley Cyrus) costume and get some yucks faux scaring folks, the FDA is acting as a responsible pa [...]
FDA Proposals Take a Fresh Look at Some Stale Food Issues
That landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the FDA unveiled four proposed amendments that will likely make a tou [...]
The FDA is Reading Your Facebook Page and They Don’t ‘Like’ What They See
In a previous post we looked at the FDA's relatively ho-hum guidance on social media. Since then, the agency has issued an interesting warning letter to a Utah-based dietary supplement [...]
It’s Time to ‘Get’ IEC Before It ‘Gets’ You
FDA medical device recalls are on the rise. An increasingly active FDA, coupled with the rise in software components for medical devices is adding up to new challenges for manufacturer [...]
