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 [...]