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San Francisco Bay Area Chapter In Person Event: Consumer Wearables in Preventive vs Reactive Health:

Consumer wearable technologies are increasingly shaping how health information is generated, interpreted, and acted upon—shifting the focus from reactive care toward preventive and personalized health insights. With the 2026 updates to FDA guidance on General Wellness and Clinical Decision Support (CDS), the regulatory landscape has undergone a seismic shift. These updates have significantly lowered hurdles for non-invasive wearables that estimate physiological parameters like blood pressure, heart rate variability, and blood glucose, allowing more products to enter the market without traditional pre-market review. However, this "loosening of red tape" introduces new complexities for regulatory professionals in defining where a wellness claim ends and a medical claim begins. This session will explore key regulatory considerations for consumer wearables in this new era of enforcement discretion. Panelists will discuss how the 2026 guidelines influence regulatory strategy, the nuances of maintaining "low-risk" status while providing clinically meaningful data, and the evolving responsibilities for post-market monitoring in a rapidly expanding ecosystem. Using real-world examples and recent case studies, we will highlight the best practices for navigating these cuts while ensuring patient safety and data integrity. Registration Fees & Deadlines Member: $15 | Nonmember: $25 | Student Member: $10 | Student Nonmember: $20 (With Promo Code) *Please reach out to a RAPS San Francisco Chapter Leader to request a Student Promo Code Learning Objectives By attending this event, participants will be able to: Analyze the 2026 updates to General Wellness and CDS guidance and their direct impact on wearable product classification. Distinguish between "wellness" and "medical-grade" claims to mitigate the risk of FDA warning letters and enforcement actions. Develop a regulatory lifecycle strategy that leverages the TEMPO pilot program and new "red tape" exemptions to accelerate time-to-market. Evaluate the data validation requirements necessary to satisfy both consumer expectations and regulatory "low-risk" criteria. Agenda 5:00-5:45 pm Check-in/Networking 5:45-6:00 pm RAPS-SF Welcome & Introduction 6:00-7:00 pm Panel Discussion: Early & Effective Regulatory Strategy in Start-ups 7:00-7:30 pm Networking & Wrap up Speakers Patricia Reis Castro Executive, Postmarket Surveillance, Abbott Juni Sarkar, Ph.D, RAC Associate Director, Regulatory Affairs, Abbott Yusi Liu Regulatory Affairs and Quality Assurance, BioIntelliSense, Inc Location Abbott Diabetes Care Inc. 1360 S Loop Rd Alameda, CA 94502 Cancellations and Refunds RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org . Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. Substitutions Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. Proof of Attendance A certificate of attendance can be downloaded from the RAPS Learning Portal following the event. Questions Contact the RAPS Support Center: Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org .

Twin Cities Chapter In Person Event: On-Label, Extra-Label, and Off-Label: Strategizing Medical Devi

This workshop is intended for regulatory and compliance professionals that navigate FDA expectations for medical device communications. It will provide comprehensive coverage of the regulatory landscape governing medical device marketing and sales, including on-label, extra-label, and off-label communications under the Food, Drug, & Cosmetic Act and FDA guidance. Through real-world case studies (including the Acclarent criminal prosecution and recent Gilead/Novartis enforcement actions), interactive exercises, and practical decision-making frameworks, participants will learn to apply established principles for managing medical device communications. Key outcomes include the following: (1) distinguish between labeling, advertising, promotion, and distribution—and why that matters for claim review; (2) understand on-label, extra-label, and off-label communications, including when extra-label information can be communicated consistently with FDA-required labeling; (3) evaluate the latest FDA guidance on medical product communications, extra-label information, and scientific information on unapproved uses into promotional review and field coaching; and (4) navigate social media platforms, including character-space limitations, user-generated content, and misinformation—using recent FDA draft guidance and warning letters as benchmarks. Through this session, participants will collaborate on hypotheticals, review sample claims, and refine decision trees and risk evaluations for medical device communications. Registration Fees & Deadlines Member: $20 |Nonmember: $40 | Student Members $0 | Student Nonmembers $0 (With Promo Code) *Please reach out to a RAPS Twin Cities Chapter Leader to request a Student Promo Code Speakers Bryan Feldhaus, JD, LL.M President, DuVal & Associates, P.A. Bryan Feldhaus, JD, LL.M., is President of DuVal & Associates, P.A. Bryan specializes in advising medical device, pharmaceutical and nutritional supplement companies on FDA law, regulations and guidance. His practice includes providing legal/regulatory advice in designing and implementing sophisticated marketing programs (considering FDA’s advertising and promotional regulations, the Anti-kickback Statute, False Claims Act and the Physician Payments Sunshine Act), conducting sales training, and interfacing extensively on behalf of companies with the FDA on promotional, inspectional and other enforcement matters. He also provides strategic advice and advocacy regarding clinical trials and regulatory submissions. Additionally, Bryan counsels companies on compliance matters, conducts compliance assessments, collaborates with clients to develop compliance programs, and provides compliance training to ensure clients understand and achieve their compliance goals in the context of their business objectives. Finally, Bryan advises medtech companies regarding their HIPAA and GDPR obligations as it relates to their relationship to patient data. Prior to joining DuVal & Associates, Bryan enjoyed a fourteen-year career as a trial and litigation shareholder at a Minneapolis law firm. As a former litigation attorney, Bryan is experienced in trial and appellate matters, is admitted to practice in state and federal courts, and is experienced in commercial litigation and intellectual property matters, including patent and trademark litigation. Bryan is a 2006 graduate from the University of St. Thomas School of Law. He obtained an LL.M. degree in Corporate Compliance and Organizational Ethics from the University of St. Thomas School of Law. He also obtained a Cybersecurity and Privacy Law Certificate from Mitchell Hamline School of Law in 2019. Location Saint Cloud State University at Plymouth 9750 Rockford Rd #100 Plymouth, MN 55442 Sponsors DuVal & Associates, P.A. Will provide dinner Cancellations and Refunds RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org . Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. Substitutions Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. Proof of Attendance A certificate of attendance can be downloaded from the RAPS Learning Portal following the event. Questions Contact the RAPS Support Center: Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org .