Biocompatibility Considerations for Early Feasibility Studies

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 resource, developed by MDIC’s EFS Biocompatibility Working Group, offers clear, risk-based biocompatibility 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.

This resource helps device developers understand what biocompatibility means during early feasibility studies and how requirements shift as devices move toward approval. This resource clarifies what’s needed at each stage, guiding teams to build risk-based evaluation plans that align with FDA guidance and ISO standards. It outlines how to identify the right tests and monitoring during EFS and when existing data or scientific rationale can replace additional testing while maintaining patient safety. You’ll also find practical direction on documenting and reporting your findings, helping your team move confidently from EFS to pivotal studies and market readiness.

How This Resource Helps Manufacturers Plan EFS
By using this resource, your team can:

• Reduce uncertainty around biocompatibility during EFS planning
• Confidently determine when prior data and scientific rationale can replace redundant testing
• Align testing and reporting practices with FDA and ISO standards
• Advance devices to EFS faster while maintaining high safety standards
• Streamline the transition from EFS to pivotal studies and market readiness

Material/Supplier Selection Under the EFS IDE Framework
Paired with this resource, MDIC has released a best practices document on materials and supplier selection offering practical strategies for device developers navigating Early Feasibility Studies. It highlights why choosing the right materials and suppliers early can simplify biocompatibility planning, reduce project risks, and help avoid unnecessary testing during EFS.