Profile: FDA’s Bakul Patel On The Inevitable Future Of Digital Health
Medtech Insight profiles the man leading the US FDA’s digital health efforts to learn about his journey and vision for the future.
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Kevin Fu, a University of Michigan associate professor, has been named the US agency’s acting director of medical device cybersecurity. In his new post he’ll be able to mold the agency’s regulatory approach.
Bakul Patel, director of the US agency’s new Digital Health Center of Excellence, tells Medtech Insight he’s looking to hire staff that want to shape the digital health regulatory landscape.
Nine companies are asked to volunteer for a pilot program that could lead to a new pathway for sponsors of digital health products. Under the plan, the agency would allow firms to market a product with fewer if any pre-market review requirements based on trust developed in the company's software design and testing. If the project works out, FDA digital health leader Bakul Patel tells Medtech Insight, the agency hopes it will attract more non-traditional medical device firms that specialize in software development.