Yarmela Pavlovic, JD
Manatt Health, San Francisco, California, USA
As a partner with Manatt, Phelps& Phillips, Yarmela Pavlovic focuses her practice on the U.S. Food and Drug Administration's premarket regulation of medical devices. She works with medical device manufacturers to develop regulatory strategies for obtaining FDA marketing approval for their devices. Yarmela brings extensive experience in product development and product submissions (510(k)s, IDEs, and PMAs), as well as a variety of other device-related regulatory issues. Yarmela has particular experience in the area of FDA regulation of digital and mobile health technology, as well as medical software and applications. From AI-based image and physiological data analysis tools, to wearable sensors and complex therapeutic delivery systems, Yarmela assists clients in assessing FDA requirements and developing premarket strategies where necessary. Yarmela has authored numerous articles and been an invited speaker on topics ranging from digital health regulatory strategies to machine learning policy development, among others.