Did you forget something on your premarket approval application?  Check it twice, because the rules have changed…again.  The FDA is now requiring manufacturers of medical devices to include pediatric patient information with all premarket approval submissions.  The Agency has even said that they may withhold approval of any applications missing such data, until the required [...]

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 [...]

Earlier this year, my510k.com was founded on an idea, to extend the conversations I had been having with colleagues in the medical device community. It seems that there are few places online to connect and collaborate about the ongoing issues regarding the industry, government, and the world market for medical technology.
Many of the stories in the [...]

It seems lately, the thing to do when one fails to achieve their desired result, is cry foul.  This can be true whether you’re an Olympic ice skater or a health policy leader.  This conclusion comes after reading the post from MassDevice interviewing Diana Zuckerman, about the recent FDA meeting reviewing the 510(k) process for clearing medical devices.  Diana Zuckerman is the president [...]