Optimizing Early Feasibility Studies: Resources for Biocompatibility and Supplier Selection
Advance Early Feasibility Studies with clear, practical resources to support biocompatibility assessments through all stages of an EFS and informed material and supplier decisions under the EFS IDE framework.
Biocompatibility Considerations for Early Feasibility Studies
This resource, developed by MDIC’s EFS Biocompatibility Working Group, offers clear, risk-based biocompatibility assessment considerations to help medical device developers efficiently plan and conduct each stage of an EFS, including initiation, transition from EFS to pivotal study, device modifications during an Investigational Device Exemption, and transition from clinical study to marketing submission.
Best Practices: Material/Supplier Selection under the EFS IDE Framework
This essential guide offers best practices for selecting materials and suppliers when developing a medical device to be evaluated under an Early Feasibility Study (EFS) Investigational Device Exemption (IDE). Explore key considerations for navigating EFS IDEs to facilitate device qualification in the early stages of development and the importance of selecting materials and vendors that meet design and functional needs, while also adhering to the highest standards of quality and collaborative integrity.
About the MDIC EFS Biocompatibility Program
The EFS Biocompatibility Program focuses on addressing biocompatibility challenges in the early stages of medical device development. This group collaborates with regulatory experts, government agencies, manufacturers, and clinical researchers to establish clear best practices for assessing the biocompatibility of new medical devices as well as materials/supplier selection.
Explore MDIC's Early Feasibility Studies Initiative
Early Feasibility Studies (EFS) are a critical gateway for bringing innovative medical devices to patients, allowing manufacturers to generate critical early evidence while advancing toward future regulatory approvals. Learn more about MDIC’s work in EFS!