Wearable and Home-use Devices Part 2: FDA Submissions

Presented by Tyler Ting, Director of Regulatory at Rook Quality Systems

In this webinar, Tyler Ting, Director of Regulatory at Rook Quality Systems, walks you through the FDA submission landscape specific to wearable and home-use devices, so you can move from development to clearance with confidence.

What we'll cover:

• How to determine the right FDA submission pathway (General Wellness, 510(k), De Novo, or PMA) for your wearable or home-use device
• Key documentation requirements and common gaps that delay or derail submissions
• How usability engineering and human factors data factor into FDA review for home-use devices
• Cybersecurity and software documentation expectations for connected and SaMD-enabled wearables
• Practical tips for responding to FDA requests and keeping your submission on track

Whether you're preparing your first FDA submission or looking to sharpen your regulatory strategy, this session delivers practical, real-world guidance tailored to the unique demands of wearable and home-use device manufacturers.