Events

Wearables Webinar Series, Part 1: Update on FDA Regulation on Wearables

October 2, 2025 | Webinar | Duane Morris LLP

Duane Morris will present a webinar, Update on FDA Regulation on Wearables, the first session in our multi-part Wearables Webinar Series, on Thursday, October 2, 2025 | 12:00 p.m. to 12:30 p.m. Eastern. 

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About the Webinar

A growing popularity of wearable devices that track consumers’ everyday health has been good for business—however, that popularity has also piqued the interest of the Food and Drug Administration (FDA). The FDA’s warning letter to Whoop Inc. in July 2025 should serve as a cautionary tale for manufacturers and others to ensure that products not intended to be a device are not marketed as a device, and do not have features that will inherently qualify them as a device.

In our first webinar, Duane Morris attorneys will discuss:

  • Medical device statutes and what is generally considered to be a medical device;
  • The FDA’s general wellness exception;
  • The Whoop Inc. warning letter and key takeaways; and
  • The importance of knowing whether your product is a medical device, and the regulatory pathways that exist for clearance or approval as a device.

About the Webinar Series

Over a series of three mini-webinars, Duane Morris attorneys will offer high-level guidance on current FDA regulations, cybersecurity and data privacy, and product liability and IP strategies for wearables.

Presenters

Frederick R. Ball

Frederick R. Ball

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Victoria Hawekotte

VictoriaHawekotte

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Coleen Hill

Coleen Hill

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About the Duane Morris Life Sciences and Medical Technologies Group

As biotech, biopharma and pharma companies develop new therapeutics, aligning legal strategies with development and commercialization goals throughout the extensive process of funding, R&D, clinical trials and market entry is imperative to a company’s strategy, success and growth. We assist clients in developing and implementing strategies to protect and expand their pipeline and maximize the benefit of their products to their target patient population.

Upcoming Webinar Sessions

October 21, 2025 – Cybersecurity and Data Privacy Concerns for Wearables

November 4, 2025 – Product Liability and IP Strategies for Wearables

About Duane Morris

Duane Morris LLP, a law firm with more than 900 attorneys in offices across the United States and internationally, is asked by a broad array of clients to provide innovative solutions to today’s legal and business challenges. Duane Morris has been recognized by BTI Consulting as both a client service leader and a highly recommended law firm.