If you want to know what changes may be in store for medical device approvals, look no further.  Change is coming, and it looks like it will start with “substantial equivalence”.  Since the Premarket Notification (510k) has been established, medical device approvals have centered around the idea of substantial equivalence to a predicate device.  Substantial equivalence means that [...]

Much has changed in the FDA over the past year, and it appears more change is to come.  Issues surrounding device approvals under the 510(k) process were front-and-center in a public meeting this past Thursday. The meeting was titled by the FDA, “Strengthening the Center for Devices and Radiological Health’s 510(k) Review Process” and [...]

Before all this talk of “Snowmaggedon”, a beaming headline posted late last week stating that, “FDA Issues Guidance to Help Streamline Medical Device Clinical Trials”.  If you were hoping to learn how it works, you were in for a statistics lesson on Bayesian methods for designing studies and analyzing clinical data.  (Wait, don’t leave!)  Good [...]

It seems like all of this new talk about reform and tightening regulations at the FDA will usher in a brave new world for the medical device industry.  Should we be worried or hopeful about pending changes to the health care system and the regulatory approval process?  To find the answer, we need only look [...]