Patent Attorney and Founder
But let’s say I have an inventor client, and they have come up with a device. Do they need any FDA certification or waiver? How do you go about answering that question for someone who has come up with something that’s sort of, you know, going to be worn on the body, and they might be doing some health care or health-related data? What things go on your mind to help them think through it? Yeah, so I have a very firm answer of maybe, right? So, um, it depends, right? So when, um, prospective clients come to me with their product, generally, the first step is going to be to conduct what we refer to as a regulatory assessment. Um, that regulatory assessment will help us to classify the device, which is how the FDA determines the regulatory pathway products need to go down for clearances, approvals, etc.