Just to take a break from the topic of pending changes in medical device regulations and the 510(k) process, this post is an opportunity to show the humanitarian efforts being made by many of the members of the Medical Device community.

The devastating earthquake in Haiti has taken an unprecedented toll of lives, which experts  feared [...]

Today, the FDA announced Phase One of its plan to be more open and transparent to the public with its operations.  The program is described in a statement issued on the Agency’s website, FDA Unveils First Phase of Transparency Initiative. This “Transparency Initiative” is part of President Obama’s campaign for more openness and accountability within [...]

In the new era of Hamburg’s FDA, it’s almost a call-to-arms when someone directly criticizes the agency for not being tough enough on Device approvals.  This is exactly what a group from Beth Israel Deaconess Medical Center in Boston and researchers from the University of California, San Francisco did just before the start of this new [...]

So, we are now 6 days into the New Year, and already I am starting to see the euphoria wearing off on my friends and colleagues.  You know, that hope that we all had at around 11:59 PM on December 31, that this time it was going to be different.  Then we counted down the [...]