Event Recap: Ski-LE –  The Mountain Summit for FDA Regulatory and Compliance Leaders

A High Altitude Sumit for FDA Regulatory & Compliance Leaders

On April 10, 2026, professionals across the medtech, biotech, pharma, and broader FDA-regulated industries gathered at the Cliff Lodge at Snowbird, Utah, for Ski-LE 2026: The Mountain Summit for FDA Regulatory & Compliance Leaders.

Set against the backdrop of the Wasatch Mountains, this in-person program brought together in-house attorneys, regulatory leaders, quality professionals, compliance teams, and business executives for a focused morning of CLE and RAPS-recognized programming on the legal, regulatory, and enforcement issues shaping decision-making across FDA-regulated companies.

The interactive program featured timely insights and practical guidance from:

• Mark Gardner, Founder and Managing Partner, Gardner Law 
• Nathan Downing, Managing Attorney, Gardner Law 
• Mike Pisetsky, Chief Legal Officer, SI-BONE 
• Kelvyn Cullimore, President and CEO, BioUtah 

Program Highlights

Ski-LE opened with a broad discussion of the state of the U.S. healthcare space and the pressure points facing regulated companies in 2026. Mark Gardner, Mike Pisetsky, Nathan Downing, and Kelvyn Cullimore helped frame a regulatory environment defined by uncertainty, agency transition, heightened enforcement, faster-moving technology, and continued pressure on companies to make legally sound decisions while continuing to innovate.

From the outset, the discussion emphasized a practical theme: FDA-regulated companies cannot wait for perfect certainty before acting. They need to understand where the legal boundaries are, where agency discretion may matter, and how to document good-faith decision-making when the regulatory landscape is still developing.

FDA, AI/ML, and the Future of Medical Product Regulation

Nathan Downing led a session on current FDA priorities and how industry can adjust. His presentation began with the legal foundations of device regulation, including the statutory definition of a medical device, the FD&C Act, the 1976 Medical Device Amendments, and the regulatory pathways that continue to structure product development today.

Downing then turned to one of the central challenges facing FDA and industry: the growth of artificial intelligence and machine learning (AI/ML) in healthcare. AI/ML technologies are moving quickly, while FDA continues to apply a regulatory framework that was not originally built for adaptive, data-driven software tools.

The session addressed how AI/ML is being used to assist diagnosis, predict surgical outcomes, support remote care, manage large volumes of clinical data, and improve patient care. But the discussion also made clear that the regulatory status of these tools depends heavily on intended use, claims, risk, clinical context, and whether a healthcare professional can independently review the basis for a recommendation.

One of the practical takeaways from the session was direct: “Regulatory status increasingly turns on how physiological measurements are interpreted, framed, and presented to users.”

Downing also discussed software as a medical device, clinical decision support, and the 21st Century Cures Act framework, including how companies may structure certain software functions to remain outside the definition of a device when the product enables a healthcare professional to independently review the basis for the software’s recommendations.

Digital Health, General Wellness, and FDA Engagement

The session also covered 2026 developments involving clinical decision support and general wellness products. Downing discussed how FDA’s approach to wellness technologies has evolved, particularly for products that measure physiological parameters such as heart rate or blood pressure.

The key distinction is increasingly whether a product simply provides wellness-related information or whether it interprets that information in a way that suggests diagnosis, abnormality, clinical action, or medical management. Claims, user interface, alerts, thresholds, and contextual framing all matter.

Downing then addressed several FDA tools and pilot programs that companies may be able to use to improve efficiency or reduce uncertainty, including:

• Breakthrough Device Designation 
• The TEMPO Pilot Program 
• The National Priority Voucher Pilot Program 
• Faster Clarifications to Meeting Minutes Pilot 
• MDUFA VI-related opportunities 

He emphasized the continued value of FDA engagement, including informational pre-submissions, issue-specific pre-submissions, requests for designation, 513(g) requests, and other communications during submission review.

The practical guidance was balanced. Companies should approach FDA engagement with confidence, while remaining clear-eyed about when escalation, appeals, or additional legal strategy may be necessary As Downing summarized, companies should 

“Companies need to know when to partner with FDA and when to challenge.”
Nathan Downing, Managing Attorney

Fraud, Abuse, Advertising, and Enterprise-Wide Compliance Risk

Mark Gardner led an interactive discussion on recent fraud and abuse cases and FDA hot topics. The session focused on the enforcement environment surrounding the Anti-Kickback Statute, False Claims Act, advertising and promotion, pricing, rebates, discounts, privacy, AI, and healthcare competition.

Gardner discussed the continued importance of copay assistance cases, speaker programs, consulting arrangements, pricing practices, rebate structures, and medtech enforcement. He also addressed the expanding role of whistleblowers and the increasing importance of documentation, governance, and operational discipline.

A core takeaway from the discussion was that FCA risk now reaches well beyond traditional billing issues. It increasingly touches pricing, contracting, data reporting, cybersecurity, patient support, promotional practices, and the way companies document their real-world compliance decisions.

As the session emphasized: 

“How you operate and document drives FCA risk.”
Mark Gardner, Founder & Managing Partner

The discussion also covered OIG Advisory Opinion 25-11, which highlights the importance of clear discount and rebate structures, proper disclosure and reporting, and accurate reflection of net price to payors. Flexible commercial arrangements may be possible, but only when supported by transparency, structure, and careful AKS analysis.

Gardner also reviewed FDA’s renewed focus on direct-to-consumer (DTC) advertising, including cease-and-desist activity and increased scrutiny of promotional claims, risk disclosures, fair balance, and net impression. The discussion reinforced that disclaimers alone are not enough to cure misleading messaging when visuals, context, or presentation create a problematic impression.

Additional topics included compounded GLP-1 marketing, the FTC’s healthcare enforcement posture, state privacy laws, website tracking litigation, and privilege risks involving public AI tools.

Tales from the Trenches: Medtech Commercialization and Compliance

Mike Pisetsky, Chief Legal Officer at SI-BONE, brought a practical in-house perspective to the program with his session, “Tales from the Trenches: A Focus on FDA Fraud, Abuse, and Marketing Compliance.”

Using SI-BONE’s experience as a case study, Pisetsky walked attendees through the evolution of sacroiliac joint fusion, the company’s product development history, clinical evidence, reimbursement pathway, FDA clearances, and changing market dynamics. His session showed how regulatory strategy, commercialization, reimbursement, physician relationships, and compliance controls must evolve together as a market develops.

Pisetsky discussed how off-label use can generate important insights, but companies must be careful not to encourage or promote off-label use. He emphasized the importance of tracking physician behavior, responding to new clinical practice patterns, and working with FDA to update labeling when evidence supports expanded indications.

The session also addressed physician investors, consulting arrangements, stock options, Open Payments reporting, physician-owned distributor concerns, CPT code transitions, grants, sponsorships, field-based promotion, meal limits, and market-building activities.

One of the practical compliance reminders from the session was concise: 

“Open Payments is your friend.”
Mike Pisetsky, Chief Legal Officer, SI-BONE

Pisetsky also emphasized that compliance programs need clear rules, documentation, training, monitoring, escalation paths, and a willingness to remediate when conduct does not align with expectations. In an intent-based AKS environment, companies need controls that employees can actually understand and apply.

Key Takeaways from Ski-LE 2026

Ski-LE 2026 reinforced several practical lessons for FDA-regulated companies:

• AI/ML and digital health products require careful attention to intended use, claims, user interpretation, and clinical context. 
• FDA engagement remains valuable, but companies need to understand when informal dialogue, formal submissions, appeals, or escalation may be appropriate. 
• Advertising and promotion risk is increasing, especially for DTC ads, social media, influencer content, compounded drug marketing, and claims that create misleading net impressions. 
• AKS and FCA exposure continues to reach across pricing, contracting, patient support, physician relationships, cybersecurity, data reporting, and documentation. 
• Medtech companies should build compliance infrastructure early, especially when working with physicians, expanding indications, navigating reimbursement, and developing new markets. 
• Practical compliance depends on operational discipline, not policies alone. 

Stay Connected

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