FDA Entrepreneurs’ Workshop :: Strategy for Medical Devices + Digital Health Products

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Medical research and tech are converging, and federal regulators are issuing guidelines to shape the future of product development and therapies. This workshop is designed for entrepreneurs who are developing medical devices and digital health products.


This session will provide an overview of the U.S. Food and Drug Administration’s (FDA’s) regulation of medical devices, covering development of regulatory premarket strategies, the approval and clearance processes, and postmarket safety and recalls. As part of this overview, the presenters will also cover timely subjects such as 3D printing of medical devices and direct-to-consumer tests for genetic risk information. The digital health component will include a discussion of the specific requirements for medical device software and review the current status of the 21st Century Cures Act as it relates to the regulation of medical device software, an evolving field that encompasses wearable technologies, health IT and cybersecurity.
The interactive workshop will be led by Seth Mailhot, Washington, DC-based patent attorney, former FDA compliance officer, partner and leader of the FDA Regulatory Practice Group at Michael Best. He will be joined by a panel of medical device and digital health entrepreneurs with first-hand experience navigating the regulatory landscape.

Sponsored by Burroughs Wellcome Fund. Thanks to our partners DHIT and COIN.


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