Yarmela Pavlovic helps medical device manufacturers get FDA marketing approval for their devices. Her wide-ranging knowledge of the FDA’s premarket requirements benefits companies seeking efficient regulatory strategies to successfully forge a pathway to market. Yarmela offers strategic plans that not only comply with government regulations, but also achieve clients’ business objectives.
She has a full understanding of product development and product submissions (510(k)s, Investigational Device Exemptions, and Premarket Approvals), as well as other device-related regulatory issues. She has particular experience in the area of FDA regulation of digital and mobile health technology, as well as medical software and applications. From standalone apps to complex systems, Yarmela assists clients in assessing FDA requirements and developing premarket strategies where necessary. Yarmela also regularly counsels manufacturers of In Vitro Diagnostic (IVD) tests.
She also advises medical device companies on advertising and promotion of medical devices through social media platforms. She provides clients with strategic advice regarding development of online marketing strategies and policies.
Recognized by her peers, she has authored a number of articles and been an invited speaker on topics related to mobile health, Health IT, and medical device premarket pathways.
Before joining Hogan Lovells, Yarmela defended medical device manufacturers and pharmaceutical companies in products liability litigation at a Philadelphia law firm. While in law school, she served as the publication manager for the Michigan Journal of Gender & Law. Yarmela also spent a summer clerking for the Portland Federal Public Defender.
Areas of Focus
Part of the team that assisted an In Vitro Diagnostic company in obtaining PMA approval for a noninvasive colon cancer screening test.
Assisted a major diabetes manufacturer in seeking PMA approval for a sensor augmented insulin pump.
Helped numerous companies in seeking 510(k) clearance.
Assisted a major health IT company in assessing product portfolio to identify FDA regulated products.