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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 [...]
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 [...]
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 F [...]
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 [...]
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 [...]
FDA IDE Guidance Offers Industry Important Clarity
In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Investigators, the FDA attempts to better o [...]
