United States Food and Drug Administration
Christina Savisaar currently serves as a Policy Analyst on a team within the Office of Clinical Evidence and Analysis (OCEA) within the US Food and Drug Administration’s Center for Devices and Radiologic Health (CDRH). This team serves CDRH, and CDRH’s vision to provide all patients in the US with access to high-quality, safe and effective medical devices of public health importance first in the world, by providing regulatory guidance to both internal and external stakeholders regarding the interpretation and application of policies and procedures related to the Investigational Device Exemption, Expanded Access, Breakthrough, and Safer Technologies Programs, as well as to clinical trial and human subject protection matters in device investigations. Before joining OCEA in 2020, Christina had been with CDRH in various capacities for over 13 years, where her responsibilities have included leading premarket reviews of medical device submissions and developing and implementing regulatory policy for the rollout of the Unique Device Identification Program.
Christina received a bachelor’s degree in biomedical engineering from Rensselaer Polytechnic Institute and a doctoral degree in biomedical engineering from the University of Iowa. Prior to her career in public service, Christina had a number of research roles in the medical device industry and in academia.
H11 - [IN-PERSON ONLY] When Secondary Data Use Involves an FDA Regulated Device Study
Wednesday, December 6, 2023
1:45 PM – 2:45 PM ET