Much has changed in the FDA over the past year, and more change is to come. While suggestions are being taken by FDA, their position seems clear that “Strengthening the 510(k) Review Process” means getting tougher on industry. For a recap of the historic meeting check the Five-Ten (...)

FDA launched new measures today opening up operations to consumers. How can we have the same openness in the 510k process for Device Makers? Read today's Five-Ten Blog.

Despite Hamberg's FDA continuing to toughen its approach, the agency is still facing increased scrutiny from those critical of its past efforts. Even though these critics claim to be advocating for the patient, FDA's reaction may stifle innovation to the detriment of very this same group. Read today's <a href="http:/(...)

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 final seconds and all was right with the world. (...)