Changes to the 510(k) process - California Healthcare Institute

The California Healthcare Institute has published a white paper titled "Upcoming changes to the 510(k) Process: New Approval Pathways and the impact on Medical Device Development and innovation", available by clicking on the "white paper" link. Interesting reading!

FDA to rescind 510(k) clearance

The FDA is taking steps to rescind the 510(k) clearance of a knee implant because they made errors in the original clearance process. Now we finally know they really are bureaucrats, even though they present themselves as being "scientific". Apparently procedure takes precedence over science. This device has so far been used in over 300 cases over a period of 10 years without any complaints. Read this article in the WSJ and don't forget to go to the Comments tab.

OCTANe's Medical Device & Investor Forum

The annual MDIF will be held this year on 25-26 October in Newport Beach, CA. For more information about the Forum, go to MDIF. Find out who will attend.

FDA's 510(k) process changes: group in Congress is pushing back

A group of 12 lawmakers from the House of Representatives asked the FDA to delay implementation of five proposed changes to the 510(k) process until the FDA provides more details. They did so in a letter to Dr. Hamburg. See the FDA Law blog for more details.

Small gets smaller and smaller...

When I went to college, integrated circuits were "small" and decreasing in size rapidly. Nowadays nanotechnologies work with structures only a few tens of nanometers in size, and researchers turn these into baffling technologies! The latest is depositing fluorescent dyes inside living cells! Even if it's way out of your everyday interest, read this article about Quantum dots.