AssurX Blog
Straight talk for regulated industries.
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 [...]
FDA IDE Guidance Offers Industry Important Clarity
In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Investigators, the FDA attempts to better outline its thought process for reviewing, accepting, accepting w [...]
Cybersecurity & Reliability Assurance Initiatives Top Priority at NERC Board Meetings
NERC held its Board of Trustees (BOT) and Member Representatives Committee (MRC) meetings in Vancouver, BC on August 13 – 14, 2014. The meeting included lively discussions on all the i [...]
FDA Guidance Advises Device Makers to Think About Home-Use
Medical device manufacturers would be well-advised to address any potential risks associated with home-use products at the design stage, according to an August guidance from the FDA. A [...]
