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.
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
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 [email protected]. 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 [email protected] 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 [email protected].
