Lina R. Kontos
Counsel
Washington, D.C.
Practice Group
Regulatory
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.
Practices
Industries
Areas of Focus
Representative Experience
Latest thinking and events
Sponsorships and Speaking Engagements
MAGI's Clinical Research Conference
23 May 2017
Philadelphia
Events
MedTech Intelligence's HHE , Benefit-Risk, Recalls conference
18 May 2017
Events
Medical Device Packaging & Labeling Summit
27 April 2017
Alexandria
Hogan Lovells Publications
New FDA Reporting Tool Encourages Whistleblowers
Medical Device AlertHogan Lovells Publications
Submission of Electronic Labeling for Home-Use Devices
FDA AlertHogan Lovells Publications
Highly Anticipated FDA Draft Guidance Documents on 510(k) Device Modifications Add New Considerations to the Decision-Making Process for Companies
Medical Device AlertView More
