Georgia Ravitz

Georgia Ravitz

Orrick, Herrington & Sutcliffe LLP

Contact
View Bio
RSS

Latest Posts › Regulatory Requirements

Share:

Will FDA’s Warning Letter to WHOOP Put a Chill on Wearables?

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more

8/6/2025  /  21st Century Cures Act , Digital Health , Enforcement Actions , FDA Warning Letters , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Regulatory Oversight , Regulatory Requirements , Wearable Technology

FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

1/8/2025  /  Artificial Intelligence , Bias , Cybersecurity , Data Management , Food and Drug Administration (FDA) , Medical Devices , Regulatory Requirements , Risk Management , Software , Transparency
2 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide