The Comment Period, Ep. 5: How I Met Your Regulator

As Gardner Law celebrates its 10th anniversary, Mark Gardner, Amanda Johnston, and Nate Downing go back to the beginning: How did each of them end up practicing FDA law?

They share the experiences, mentors, career changes, and occasional unexpected turns that brought them into FDA-regulated industries and ultimately together at Gardner Law. From medical device regulatory affairs and in-house compliance to biotech, neuroscience, and a chance meeting with a law professor, their paths were different, but each led to work at the intersection of science, law, and business.

Then the conversation turns to an area generating plenty of questions today: clinical decision support software (CDS). Mark, Amanda, and Nate discuss why CDS is gaining momentum, how AI is making sophisticated software easier to develop, and how FDA distinguishes certain decision-support tools from regulated medical devices.

They also explore why developers should understand the applicable FDA framework before they build, how FDA evaluates risk and physician involvement, and where clinical decision support may fit into the future of healthcare.

The Comment Period: How I Met Your Regulator is now open.

Watch below, or listen and subscribe on Spotify, YouTube, or Apple Podcasts