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Lina Kontos' technical engineering background lets her craft strategic and creative solutions for companies facing regulatory matters before the U.S. Food and Drug Administration (FDA). She works exclusively with medical device companies with a deep focus on the premarket clearance and approval of new medical devices.
Lina leverages her professional experience to view medical devices both from the company's perspective in designing and marketing a new product and from the perspective of an FDA reviewer. She has wide-ranging experience in assisting companies in matters pertaining to product development, regulatory strategy and product submissions (pre-submissions, 510(k)s, IDEs, de novo petitions, and premarket approval applications (PMAs). She works with companies through the entire medical device life cycle, providing advice from the product development phase in order to optimize the regulatory pathway, helping to navigate the FDA process in determining the testing and information necessary to get to market, presenting the strategy to FDA, and advising on issues once a product is being distributed, including advertising and promotion and diligence for mergers and acquisitions.
Her interest in technology and development carries over into her law practice helping tech companies with determining when and how medical device regulation applies and navigating FDA's evolving regulations in digital health. Lina has special experience with devices intended to be sold over-the-counter (OTC) and the accompanying usability and human factors evaluations to support those applications, radiation emitting products in both medical and nonmedical applications, and FDA's requirements for Unique Device Identifiers (UDI).
Prior to joining Hogan Lovells, Lina worked as a biomedical engineer and reviewer in the Office of Device Evaluation/Center for Devices and Radiological Health at the FDA. While at the FDA, she evaluated 510(k) notices, investigational device exemption applications (IDEs), and PMAs for peripheral vascular medical devices. Now Lina utilizes both her engineering background and FDA experience in advising clients on getting new and novel products to market.
Advise companies on FDA's regulatory guidance on clinical decision support apps, interactive tech for health and fitness, and patient monitoring.
Worked with numerous companies to obtain FDA clearance for OTC cosmetic devices for treatment of wrinkles.
Successfully appealed FDA order for a multi-million dollar multi-year postmarket study.
- J.D., Georgetown University Law Center, 2006
- B.S., Carnegie Mellon University, 2002
- District of Columbia
4 June 2020