In this episode of The Comment Period, Mark Gardner, Amanda Johnston, and Nate Downing go back to the beginning. As Gardner Law celebrates its 10th anniversary, they share the experiences, mentors, unexpected career turns, and very different paths that brought them into FDA-regulated industries and ultimately together at Gardner Law.

Then the conversation turns to one of the areas keeping them especially busy today: clinical decision support software. They discuss why CDS is gaining momentum, how AI is changing what developers can build, where FDA draws the line between unregulated decision-support tools and regulated medical devices, and why understanding that line before you start building can save considerable time and expense.

Plus, there is some recruiting, a little reminiscing, and further confirmation that FDA lawyers can, in fact, nerd out for more than 30 minutes.

In Episode 4 of The Comment Period, Mark Gardner and Nathan Downing are joined by Gardner Law attorney Brynn Stanley to break down the FDA recall process and the decisions companies need to make when an issue arises. They discuss Class I, II, and III recalls, health hazard evaluations, risk management documentation, market withdrawals, medical device reporting, postmarket surveillance, and how FDA evaluates a company’s response

The conversation covers wearables moving deeper into healthcare, the evolving GLP-1 compounding and peptide market, and the challenge of regulating generative AI-enabled medical devices. They also discuss emerging cancer treatments, personalized medicine, and the FDA programs that can help promising products reach patients faster.