FDA Biocompatibility in 2026: What to Test, What to Justify, and What to Submit

Overview

A medical device can undergo extensive biocompatibility testing and still encounter significant questions during FDA review. Testing performed on an unrepresentative device configuration, inadequately documented extraction studies, or toxicological assessments based on unsupported assumptions can undermine an otherwise comprehensive biological safety evaluation. These deficiencies often surface after manufacturers have invested considerable time and resources in testing, potentially leading to additional information requests, repeated studies, and delays in bringing a device to market.

Recent FDA developments have placed renewed attention on how manufacturers approach biological evaluation. In May 2026, FDA partially recognized ISO 10993-1:2025, introducing updated considerations for evaluating biological safety within a risk management framework. While the agency continues to accept declarations of conformity to the recognized 2018 edition through July 1, 2029, manufacturers must understand how the updated standard aligns with FDA's current recommendations. FDA reinforced these expectations through three technical town halls in September and October 2026, addressing biological risk assessments, chemical characterization, extraction testing, and toxicological risk assessments. During these discussions, FDA reported identifying 32 deficiencies across a targeted sample of 19 fiscal year 2025 additional information letters involving chemical characterization or toxicological risk assessment. Many concerned unclear testing methodologies, inadequate extraction details, and insufficient supporting documentation.

For medical device manufacturers, the challenge extends beyond selecting the appropriate tests. Determining whether existing evidence adequately addresses biological safety requires careful evaluation of device materials, patient-contact characteristics, manufacturing processes, sterilization methods, and previous testing. Even relatively limited changes to a material, supplier, or manufacturing process can raise questions about the continued applicability of earlier results. Manufacturers also need to establish whether the selected test articles represent the finished device, whether chemical characterization studies provide sufficient information for toxicological evaluation, and whether exposure calculations and safety conclusions are scientifically justified.

This webinar will examine FDA's current biocompatibility expectations and the practical application of the ISO 10993 framework, with particular attention to ISO 10993-1, ISO 10993-18, and ISO 10993-17. Participants will learn how to develop risk-based biological evaluation plans, determine which biological endpoints require assessment, evaluate the adequacy of existing evidence, and establish defensible testing strategies. The session will explore representative test-article selection, extraction-study design, analytical data interpretation, toxicological risk assessment, exposure calculations, margins of safety, and the preparation of supporting documentation for FDA submissions.

Drawing on FDA's recent technical discussions and examples involving device modifications, laboratory testing, and submission deficiencies, the program will examine where biological evaluations commonly fall short and how those weaknesses can be addressed. Participants will learn what to examine in laboratory proposals and completed reports, how to identify gaps between testing results and scientific conclusions, and how to organize evidence that supports the biological safety of the finished device. The objective is to help regulatory affairs, quality assurance, R&D, and biological safety professionals make better-informed testing decisions, improve oversight of outsourced testing activities, and prepare biocompatibility documentation that can withstand closer regulatory examination.

Areas Covered During the Session

• FDA’s Current Biocompatibility Expectations and ISO 10993-1:2025
• FDA Recognition Limitations and the Transition from ISO 10993-1:2018
• Building a Risk-Based Biological Evaluation Plan
• Determining Contact Categories, Exposure Duration, and Relevant Biological Endpoints
• Using Existing Data, Material Information, and Prior Device Experience
• Developing Scientific Justifications for Additional Testing Decisions
• Intact-Skin Devices and Material-Mediated Pyrogenicity Assessments
• Selecting Representative Test Articles and Worst-Case Configurations
• Evaluating Material, Supplier, Manufacturing, and Sterilization Changes
• Chemical Characterization and Extraction Study Design
• Reviewing Analytical Data and Its Suitability for Toxicological Assessment
• Toxicological Risk Assessment, Patient Exposure, and Margins of Safety
• Reviewing Laboratory Reports, Deviations, and Unexpected Findings
• Preparing Biological Evaluation Reports and Supporting Submission Documentation
• Addressing Evidence Gaps and Seeking FDA Pre-Submission Feedback

Why Should You Attend?

If you are responsible for approving a biocompatibility testing plan, reviewing laboratory results, or preparing biological safety documentation for FDA submission, the quality of the decisions made before and after testing matters. This webinar will help you recognize where testing strategies and supporting evidence may be inadequate, allowing you to raise the right questions before committing resources or finalizing a submission.

You will gain practical insight into assessing the scientific basis for testing recommendations, determining when previous data can be relied upon, and reviewing chemical characterization and toxicological risk assessment reports. Understanding these details will help you evaluate the work performed by external laboratories and consultants, identify questionable assumptions, and ensure that important biological safety concerns receive appropriate consideration.

The program will also help you interpret FDA's current expectations alongside the updated ISO 10993 framework and apply them to your organization's evaluation and documentation practices. By examining common deficiencies and the decisions that contribute to them, you will be better prepared to review biological evaluation packages, explain testing decisions to internal stakeholders, and support more efficient and defensible regulatory submissions.

Who will benefit?

This webinar is designed for medical device professionals responsible for planning, conducting, reviewing, or approving biocompatibility evaluations and supporting documentation for FDA submissions. It is particularly relevant to those involved in biological safety assessments, testing decisions, toxicological evaluations, and regulatory compliance, including:

• Regulatory Affairs Directors and Managers
• Regulatory Affairs Specialists
• Regulatory Submission Specialists
• Biocompatibility Managers
• Biocompatibility Scientists and Engineers
• Biological Safety Evaluation Specialists
• Medical Device Toxicologists
• Toxicological Risk Assessment Specialists
• Chemical Characterization Specialists
• Extractables and Leachables Scientists
• Materials Scientists and Engineers
• Medical Device R&D Engineers
• Product Development Engineers
• Design Assurance Engineers
• Quality Assurance and Quality Engineering Managers
• Preclinical Safety Scientists
• Biocompatibility Testing Laboratory Managers