FDA’s Regulation of Digital Health Wearables & Sensors – Webinar Recording/Transcript
FDA’s Regulation of Digital Health Wearables & Sensors
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The market for digital health wearables and sensors is expanding rapidly.
If you aren’t familiar with how the FDA regulates these device technologies, you might miss the nuanced interpretations that can help you delineate the regulatory requirements for apps versus hardware and other aspects of product development.
Join FDAnews and experts Kristin Davenport and Christina Kuhn for a comprehensive overview of the FDA’s regulation of digital health wearables and sensors.
Key Presentation Takeaways:
- Evaluate the developing landscape for digital health wearables and sensors, including examples of the breadth and depth of their development processes
- Determine which FDA’s policies apply when wearables are regulated, including how to comply with the FDA’s guidances on clinical decision support
- General wellness products
- Medical device data systems
- Other exempt software under the 21 Century Cures Act and FDA’s Mobile Medical Apps Guidance
- Specify differences between platforms and individual apps
- Assess considerations for artificial intelligence and the intersection of artificial intelligence and the FDA regulation
- Identify which medical device requirements are for regulated wearables
Implement innovative strategies for faster, streamlined approvals of your wearables and sensors.
Meet Your Presenters:
Kristin Davenport, Of Counsel, Covington & Burling LLP
Ms. Davenport advises medical device companies regarding pre-market strategies and pathways, the pre-market submission process, advertising and promotion, compliance and enforcement matters, and import/export issues. She has extensive experience with 510(k) pre-market notifications, de novo petitions, pre-market approval applications, investigational device exemptions, device modifications, 513(g) Requests for Information, MDR reporting, device recalls, and Part 806 reports.
Christina Kuhn, Associate, Covington & Burling LLP
Ms. Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products. Ms. Kuhn frequently helps multinational device manufacturers as well as start-up device companies navigate the pre-market regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions.
Who Will Benefit:
- Medical device specialists
- App developers
- Software regulatory and quality specialists
- Strategic planners