Gardner Law

🚨Food Additive Bans Are Here In 2025, West Virginia and Virginia joined California in banning several synthetic food additives—especially in school meals. Two days ago, the FDA announced a plan to phase out all petroleum based dyes. And at the same time, the FDA is reconsidering how it handles GRAS designations—raising the bar for safety documentation and public transparency. Food makers need to adapt to these changes now, or they will get left behind. Are you prepared? Read the latest from David Graham to find out what you can do, and let us help you: ✔ Audit ingredient risks ✔ Prep for new compliance deadlines ✔ Rethink your GRAS strategy 📖 https://lnkd.in/gngHGQaq #FoodLaw #GRAS #FDA #Compliance #FoodAdditives #SchoolNutrition #FoodManufacturing #CPG

Spring into Compliance at Surly Brewing Co. 🍺 We're one month out from the event of the s̶a̶i̶s̶o̶n̶ season! Join us on May 22 from 12–3 PM CDT for Saison-al Session: A Legal Update for FDA-Regulated Industry—a complimentary in-person (or livestreamed) event. The course is pending approval for 2.5 #CLE and Regulatory Affairs Professionals Society (RAPS) recertification course credits, and will feature: ✅ 5 fast-paced sessions from attorneys, including Mark Gardner, MBA, Esq., Amanda Johnston, Nathan Downing, David Graham, Paul Rothermel, Rebecca Zadaka, Brynn Lund Stanley, Katy Herman and Darya Lucas. ✅ Insights into fraud enforcement, AKS/FCA risks, privacy trends & more. ✅ A powerhouse panel led by Mark Gardner, MBA, Esq. and featuring legal and compliance leaders Bryan Phillips (Inspire Medical Systems), Frank Piskolich (ZOLL Medical Corporation), Jonelle Burnham (CVRx | Barostim), and Wendy Cusick (former Spineology Inc.). ✅ Post-session reception at a Twin Cities landmark institution. Come to learn, grab a drink, enjoy a bite––and stick around for a golden opportunity to network with execs, attorneys, and QA/RA professionals over something seasonal. Learn more here and register to claim your seat at the table: https://lnkd.in/gUYKVz5D #FDA #Compliance #Regulation #privacy #litigation #HealthcareLaw #Medtech #MinneapolisEvents

Calling all #innovators, #inventors, #entrepreneurs, #engineers, and #physicians who are interested in hearing a panel of seasoned #Medtech experts sharing their insights and guiding you through the critical steps of medical device development? There's still time to sign up for this free webinar! Chrysalis Incubator founders Mark Gardner, MBA, Esq., Darryl B., Brendon Pittman and Benjamin Tramm are presenting "Disciplined Innovation: From Concept to Market in Medical Technology" today, April 23rd, from 12:00pm-1:00pm. Register here: https://lnkd.in/gjd2kEey

Friends: I recently co-founded Chrysalis Incubator with three partners: Darryl B., Brendon Pittman, MBA, and Benjamin Tramm, EE, Esq.   Tomorrow, we’re hosting a 60-minute program focused on what inventors need to do to take a medical device from concept to market. If you’re interested in attending, it starts at noon CST, and you can register here:   https://lnkd.in/gCPbfUy3.   Feel free to pass the invite along. Thanks! -Mark #medtech #medicaldevice #entrepreneur #intrapreneur #inventor #incubator

Ski-LE was a hit! On April 11, Gardner Law's Mark Gardner, MBA, Esq. and Nathan Downing and SI-BONE's Mike Pisetsky welcomed professionals across medtech, laboratory, and biotech sectors to Snowbird Resort for four hours of #CLE and #RAPS-approved programming—plus a mountain view and ski slopes that didn’t disappoint. Attendees dug into: ✔️ FDA enforcement and policy shifts amid political turnover ✔️ Major changes to the U.S. healthcare system ✔️ Key regulatory considerations for the total product lifecycle ✔️ Real-world fraud and abuse cases—and how to avoid the same fate ✔️ A firsthand look at scale-stage legal challenges from a successful medtech founder From Anti-Kickback pitfalls to premarket planning, we covered the terrain. Missed the event? A recap and presentation materials are available here: https://lnkd.in/g96xKHfS And mark your calendar and subscribe to our alerts so you don't miss when registration opens for our return to Snowbird in April, 2026! Subscribe: https://gardner.law/signup #FDAcompliance #Healthcare #SkiLE2025 #RegulatoryStrategy #MedTechCompliance

Routine documents—emails, meeting notes, text messages—can make or break a company’s legal defense. From careless phrasing to “harmless” humor, poor documentation habits have exposed companies to billions in liability. Just ask Big Tobacco. In our latest alert, Gardner Law Senior Counsel David Graham previews what you’ll learn in his upcoming CLE Webinar, “What’s on File Could Be on Trial.” He describes the pitfalls that can turn internal communications into courtroom liabilities—and shows how to write smart documents that protect your organization. Follow the link below to read the alert and sign up for this free, two-part series, where you are guaranteed to receive: ✅ Actionable guidance for navigating ambiguity ✅ Real-world examples of how companies have gone wrong ✅ Best practices you can implement immediately to mitigate risks https://lnkd.in/gfp2tEFu #LitigationRisk #LegalTips #Documentation #CLE

Bringing a medical device from idea to market? Don’t go it alone. Join us for a free, practical webinar featuring our founding partners Mark Gardner, MBA, Esq., Brendon Pittman, Darryl B.arnes, and Benjamin Tramm, MedTech experts who will share their insights and guide you through the critical steps of medical device development. You will learn what works (and what doesn’t) when launching your device in today’s regulatory and commercial landscape. Whatever stage you're in with your device, Chrysalis can take you to the finish line and beyond. 📅 Tuesday, April 30 | 12–1 P.M. CDT Register here: https://lnkd.in/gcMbRece #MedTech #MedicalDevices #StartupTips #FDA #Innovation

Medical Technology Leaders: Are you building your company for long-term growth—or a successful exit? Gardner Law's Amanda Johnston and Paul Rothermel recently teamed up with leaders from BMO Capital Markets, including Marc Ogborn, Trushar Patel, and Kevin Kim, to host a powerful session for MedTech #founders and CEOs, offering clear, actionable insights on preparing for #Mergers & #Acqusitions and #IPO opportunities. From #compliance and #cybersecurity to investor storytelling and deal timing, our panel covered everything you need to know to sharpen your strategy and increase your valuation. 📘 Read the recap for practical advice on your next deal: https://lnkd.in/gPF-NErn 📽️ Watch the recording on our YouTube Channel: https://lnkd.in/gUtPvU-r

How do you unlock the power of AI while staying on the right side of HIPAA? Join Gardner Law Senior Attorney Paul Rothermel on Thursday, May 8 at 12 PM CT for a one-hour webinar exploring the latest in #AI #regulation and how recent advancements in the tech interact with #HIPAA and other #privacy laws. You'll leave with practical insights into how to deploy AI in a compliant, risk-conscious manner in the medical technology space. Register at the link below to reserver your spot. https://lnkd.in/g5XqM9jc #Medtech #Compliance

In #FDA-regulated industries, policies should be more than a binder on the shelf or a PDF on a shared drive. They should be used, referenced, and understood. We just published an alert on how to bring compliance policies to life—plus a complimentary #Compliance Program Checklist to help you assess where your program stands. At the link below, you'll find: ✔️ Practical tips for building policies people actually use  ✔️ Common pitfalls (like relying on generic templates)  ✔️ How to reinforce key policies all year—not just at annual training Read the full post + download your complimentary checklist: https://lnkd.in/gBjJkYFQ. If you need help tailoring your policies to fit your business and risk profile, we’re here to help.  #MedicalDevices #Pharma #HealthcareCompliance #RiskManagement