FDA Regulatory Environment for Wearables, Implantables, and Other Digital Health Devices – Wearables Crash Course Webinar Series
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Take a coffee break every Tuesday in June at 2 p.m. ET to join us for a 15-minute webinar covering trending wearable health technology issues!
We know that you are busy and want to stay current on trending issues. To meet this need, we are offering a “crash course” webinar series. You can pick and choose sessions to attend or sign up for all five 15-minute sessions, depending on your availability and level of interest. In each compact, 15-minute installment, we will guide you through a different wearable health technology issue. This webinar series should be of interest to medical device and technology providers and consumers, and other health care stakeholders.
This week's session:
FDA Regulatory Environment for Wearables, Implantables, and Other Digital Health Devices
Presenter: Bonnie I. Scott
Whether wearables and other digital health products are subject to regulation by the U.S. Food and Drug Administration (FDA) is largely a question of how these products are intended to be used. Although FDA has indicated that low-risk, consumer wearables, such as Fitbits, will not be the focus of regulatory oversight, higher-risk, “medical grade” products will likely be subject to FDA scrutiny. This session will review the regulatory landscape surrounding wearables, implantables, and digital health devices.
Have a question about these issues? Please email the session speaker or Sylwia Faszczewska, Marketing Coordinator, at [email protected].