Best Practices: Material/Supplier Selection under the EFS IDE Framework

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. Yet, navigating biocompatibility requirements during these early stages can create barriers that delay progress.

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. Such diligence is critical for ensuring biological safety before collecting clinical evidence. While it can be challenging to secure all the material and processing information outlined in this resource, consider this list as a guide towards achieving transparency and disclosure between suppliers and study sponsors.

Overview of Best Practices for Material and Supplier Selection

• Form a cross-functional team (microbiology, sterilization, biocompatibility, regulatory, material science, procurement, supplier quality) to guide selection.
• Prioritize suppliers with strong regulatory compliance, quality systems, and transparency to mitigate risks and testing burdens.
• Confirm material performance, prior use, and absence of chemicals of concern while leveraging existing biocompatibility data where possible.
• Establish clear supplier agreements and change notification processes to maintain oversight and documentation for regulatory needs.

This document is released as a supplemental resource to the EFS Biocompatibility Considerations resource. It expands on the principles outlined in that guide by providing focused best practices for selecting materials and suppliers within the EFS IDE framework. By aligning supplier and material selection with your biocompatibility strategy, teams can streamline the early feasibility process while maintaining high standards of safety and quality, ensuring that device development efforts are efficient, compliant, and patient-centered.