Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Christina Savisaar, PhD
Policy Analyst
Policy and Operations Team 1
Division of Clinical Evidence and Analysis (DCEA1)
Office of Clinical Evidence and Analysis (OCEA)
Office of Product Evaluation and Quality (OPEQ)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
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.
Abstract
Christina Savisaar’s presentation addresses the crucial role of clinical trials in medical device innovation while navigating regulatory requirements to ensure patient safety. She highlights the Investigational Device Exemption (IDE) regulations (21 CFR 812), which work in conjunction with Good Clinical Practice (GCP) rules (21 CFR 50/56) regarding human subject protection and IRB review. Determining if a clinical investigation requires an IDE involves first checking if it’s an exempt study. If not exempt, a study risk determination classifies it as non-significant risk (NSR) or significant risk (SR), a determination made per protocol. NSR studies primarily require IRB approval which serves as the FDA surrogate. SR studies necessitate both FDA and IRB approval of a formal IDE application. The presentation also explores efficient evidence generation through Real World Evidence (RWE) derived from routine data sources, and the utility of Early Feasibility Studies (EFS) for evaluating devices early in development, potentially before design finalization. Additionally, voluntary FDA programs like the Breakthrough Devices program and Safer Technologies program (STeP) expedite development and review for innovative devices meeting specific criteria through enhanced sponsor engagement. Understanding these requirements and engaging early with the FDA is vital for successful clinical trials.