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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 [...]
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 t [...]
FDA Spreads Regulatory Love Nationwide
Detroit may be struggling with bankruptcy. However, in a flurry of activity that would make industrialist Henry Ford pro [...]
Time to Take a Closer Look at FDA MDDS Moves
The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as [...]
