The Comment Period

How exactly does someone end up practicing FDA law?

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.

When a potential product problem surfaces, how do you know whether it calls for a recall, a market withdrawal, or another type of field action?

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

In Episode 3 of The Comment Period, Mark Gardner, Amanda Johnston, and Nathan Downing look at what happens when fast-moving technologies and markets collide with FDA regulation.

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.

Gardner Law attorneys Mark Gardner, Amanda Johnston, and Nathan Downing discuss several fast-moving developments affecting FDA-regulated companies, including FDA’s use of its ELSA AI tool in regulatory review, recent Sunshine Act enforcement, and changes to Medicare coverage pathways for breakthrough devices. The conversation also covers RAPID and NTAP, compounded peptides, the practical challenges of preparing submissions for an AI-assisted review environment, and what these policy shifts could mean for compliance, reimbursement, and commercialization.

In the debut episode of The Comment Period, Gardner Law attorneys examine how shifts in FDA leadership, policy, and enforcement are affecting FDA-regulated companies. The discussion covers direct-to-consumer advertising, AI at FDA, Whoop, peptides, digital health, and the practical challenges companies face when regulatory expectations are changing faster than the formal rules.