Schedule

Our agenda will be available the week of the conference. Sessions will include formal speaker presentations, case studies, and panel discussions. Breaks include coffee & light snacks, and lunch will be provided all three days. Please also join us for a reception event with drinks and hors d’oeuvres on the first night.

Agenda Topics for RegAF 2027

• Is Your AI Baby Ugly?: What FDA Actually Wants to See in 2026 - Jay Vaishnav

• Biocompatibility: It's More Complicated Than “We've Used Silicone Forever - Kristy Katzenmeyer-Pleuss

• De Novo: The Middle Child of FDA Pathways - Allison Kumar

• PMA: Welcome to the Big Leagues - Pablo Morales

• Your Pre-Sub Is Not Therapy: How to Get Useful Answers From FDA - Caroline Rhim

• The 510(k) Was Never the Problem: Why bad regulatory strategy starts long before the submission - Melissa Hall

• The User Did What?! Human Factors Lessons from FDA (this one for now) - Shannon Hoste

• From Printer to Patient: Who’s the Manufacturer Now? - Laura Gilmour

• Don't be Predetermined to Fail: PCCP Best Practices for Idiots - Alex Cadotte

• There’s a Guidance for That! (Why following every FDA guidance document literally can still get you into trouble) - Michael Nilo

• We Changed One Tiny Itty Bitty Thing… Do We Reaaaaally Need a New 510(k)? - Mike Ryan

• It’s Complicated: The FDA Regulatory Reality of Combination Products - Keith Christopher

• FDA Said No. Now What? - Veronique Li

Need to Make the Case to Your Boss?

We get it. Professional development has to make sense on paper, too.

RegAF brings together former FDA insiders and MedTech professionals for three days of candid conversations, practical regulatory insights, and connections with people who get what you do. Think fewer generic conference takeaways and more real-world perspectives you can bring back to your team.

Why RegAF Is Worth the Ask

1. Learn Alongside People Who Get It

More than half of RegAF attendees hold Director-level or C-suite roles, and more than 67% lead teams or projects. You’ll be in a room with people navigating many of the same regulatory challenges, asking the same tough questions, and figuring out what’s next.

Organizations represented at RegAF have included Medtronic, Stryker, Boston Scientific, Dexcom, Quidel, Werfen. However, we pride ourselves on the number of smaller startups and companies who are learning how to prepare for FDA interactions or improve their regulatory submissions.

2. Bring Back Insights You Can Actually Use

From 510(k) and De Novo submissions to PMAs, diagnostics, and international regulatory considerations, RegAF digs into the topics that matter in the real world. Hear candid perspectives from former FDA employees, get a better handle on evolving expectations, and bring fresh thinking to the challenges on your desk.

3. Your Team Benefits, Too

You don’t have to keep the good stuff to yourself. Bring back key takeaways, share new perspectives with your colleagues, and help your regulatory, quality, clinical, and R&D teams put what you learn into practice.

Three days away can spark conversations that keep going long after you’re back at your desk.

RegAF by the Numbers

• 53%+ Director-Level and C-Suite Attendees

• 67%+ Attendees who lead teams or projects

• 35+ MedTech manufacturers and specialized consultancies represented

• 100% Former FDA speaker lineup

Three Steps to Getting the Green Light

1. Find Your Why: Take a look at the RegAF agenda and pick three to five sessions that connect to your current projects, upcoming submissions, or team's regulatory priorities.

2. Do the Math: Factor in registration, travel, and accommodations. And don't forget the discounted conference hotel rate and available early-bird pricing.

3. Make Your Case: We've made it easier with a customizable manager request letter you can tailor to your goals and share with your boss.

Ready to make your case? Explore the agenda, crunch the numbers, and let's get you to San Diego.

Bring your regulatory nerdiness. We'll bring the former FDA experts!