Lina R. Kontos
Lina Kontos works exclusively on medical device regulatory matters before the U.S. Food and Drug Administration (FDA), with a focus on the premarket clearance and approval of new medical devices.
Lina 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)), as well as providing advice on a variety of other device-related regulatory issues. Lina also had special experience on devices intended to be sold over-the-counter (OTC), radiation emitting products, UDI implementation, and advertising and promotional issues.
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. In that position, she evaluated 510(k) notices, investigational device exemption applications (IDEs), and PMAs for peripheral vascular medical devices.
Areas of Focus
Routinely assists and advises clients with drafting premarket submissions to obtain 510(k) clearance, de novo reclassification, or PMA approval of medical devices
Successful appeal of a 522 post-market study order
Obtained clearance for a new over-the-counter device for stress urinary incontinence and advise other companies on devices for the treatment of pelvic organ prolapse (POP)
Advise large technology companies on the development of new apps and products in the digital health space