Lina R. Kontos

She brings a unique perspective informed by both industry and FDA review experience, enabling her to guide clients through every stage of the product life cycle. Lina advises on product development, regulatory strategy, and submissions—including pre-submissions, 510(k)s, IDEs, de novo requests, and PMAs. Her counsel spans from early design phases to post-market considerations, helping companies optimize regulatory pathways, determine necessary testing, present strategies to FDA, and address issues related to advertising, promotion, change control, adverse event reporting, enforcement actions, and diligence for mergers and acquisitions.

Lina’s passion for technology and innovation extends to her work with companies at the forefront of innovation, where she helps determine when and how medical device regulations apply and navigates FDA’s evolving policies on software and digital health. She has extensive experience with over-the-counter (OTC) devices both in the wellness space with companies seeking to understand the line between regulated and non-regulated as well as those bringing healthcare to the home, robotic systems, cardiovascular devices, and women’s health products.