Understanding the September 2024 FDA Guidance on Chemical Analysis (ISO 10993-18) for Biocompatibility Assessment of Medical Devices
In September 2024, the U.S. Food and Drug Administration (FDA) released new guidance titled “Chemical Analysis for Biocompatibility Assessment of Medical Devices.” This guidance introduces significant updates and expectations for chemical analysis in the context of biocompatibility evaluations, aligning with global regulatory trends and emphasizing the importance of rigorous safety assessments. This document aims to provide manufacturers and stakeholders with a comprehensive understanding of what’s new, expected, and its implications for compliance and how it relates to ISO 10993-18:2020+A1:2022
What’s New in the September 2024 Guidance on Chemical Analysis?
The September 2024 FDA Guidance on Chemical Analysis outlines detailed recommendations for conducting chemical analyses to support biocompatibility assessments. Key highlights include:
Section
Expanded Scope of Chemical Characterization
Threshold of Toxicological Concern (TTC)
Analytical Method Validation
Risk-Based Approaches
Enhanced Reporting Requirements
Degradation assessment clarity
Key Updates
Includes thorough identification and quantification of extractable and leachable compounds. Testing must simulate real-world conditions of use.
Introduces TTC as a critical tool for determining whether detected chemicals require toxicological risk assessments.
Requires stricter validation for analytical methods, including accuracy, precision, sensitivity, and reproducibility.
Aligns with ISO 10993-1:2018, emphasizing a risk-based approach for chemical characterization.
Mandates comprehensive test reports with detailed descriptions of methods, findings, and justifications.
This document can also be used for chemical characterization (e.g. the identification and/or
quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
Section | Key Updates
Expanded Scope of Chemical Characterization
Includes thorough identification and quantification of extractable and leachable compounds.
Testing must simulate real-world conditions of use.
Threshold of Toxicological Concern (TTC)
Introduces TTC as a critical tool for determining whether detected chemicals require toxicological risk assessments.
Analytical Method Validation
Requires stricter validation for analytical methods, including accuracy, precision, sensitivity, and
reproducibility.
Risk-Based Approaches
Aligns with ISO 10993-1:2018, emphasizing a risk-based approach for chemical characterization.
Enhanced Reporting Requirements
Mandates comprehensive test reports with detailed descriptions of methods, findings, and
justifications.
This document can also be used for chemical characterization (e.g. the identification and/or
quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
Degradation assessment clarity
The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
Global and EU Perspectives: SCHEER and European Commission Highlights
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) within the European Commission has echoed similar sentiments in its
evaluations, particularly concerning:
• Chemical Safety in High-Risk Devices:
SCHEER’s recent reports highlight the importance of chemical characterization in reducing patient exposure to potentially harmful substances.
• Convergence with FDA Guidance:
The EU’s focus aligns with the FDA’s emphasis on detailed extractables and leachables testing, ensuring harmonization between major markets.
• Chemical Safety in High-Risk Devices:
• Convergence with FDA Guidance:
SCHEER’s recent reports highlight the importance of chemical characterization in reducing patient exposure to potentially harmful substances.
The EU’s focus aligns with the FDA’s emphasis on detailed extractables and leachables testing, ensuring harmonization between major markets.
Manufacturers operating in both the U.S. and EU markets must harmonize their approaches to meet these evolving standards, benefiting from a consistent
global strategy.
Amend title to Integrated Risk Management Standards Supporting Compliance
The integration of key standards such as ISO 10993-1:2018, ISO 10993-17:2023, and ISO 18562-1:2017 with ISO 14971:2019 enhances the effectiveness
of risk assessments and post-market surveillance (PMS) activities. Together, these standards:
• Ensure a systematic and comprehensive evaluation of risks, including biological, toxicological, and chemical considerations.
• Promote alignment between pre-market risk assessments and ongoing post-market activities, ensuring continuous improvement.
• Facilitate global regulatory compliance by harmonizing approaches to risk management and surveillance.
In addition, ISO/TR 20416:2020 provides essential guidance for conducting PMS. This standard emphasizes the importance of continuous monitoring and assessment of risks throughout the lifecycle of a medical device.
Continuous Post-Market Surveillance of Risks
Manufacturers must undertake ongoing PMS activities to:
• Monitor device performance and safety in real-world settings.
• Identify and mitigate emerging risks promptly.
• Ensure compliance with evolving regulatory requirements and standards.
By leveraging these integrated standards, manufacturers can maintain a proactive approach to risk management, safeguarding patient safety while ensuring regulatory success.
Implications for Manufacturers following September 2024 FDA Guidance
1. Increased Complexity and Burden
• The guidance introduces more detailed and resource-intensive testing requirements, raising costs and time investments for compliance.
• Smaller manufacturers may need additional resources to meet these heightened expectations.
2. Regulatory Risk
• Non-compliance with the updated guidance could result in delays or rejection of regulatory submissions, emphasizing the need for early preparation.
3. Opportunities for Streamlined Submissions
• Adhering to these rigorous standards may reduce regulatory queries and improve the likelihood of first-round approval.
How CLIN-r+ Can Help
The September 2024 FDA Guidance on Chemical Analysis implies that navigating these changes can be challenging, but CLIN-r+ offers tailored solutions to support compliance:
- Gap Assessments: Identify discrepancies between current practices and new requirements in you current biocompatability evaluation submissions.
- Testing Coordination: Lets bring the best accredited labs to you that meets yoru timeline and budget to meet FDA and global standards.
- Regulatory Strategy Development: Align your biocompatability evaluations submissions with FDA and EU expectations for streamlined approvals.
- Training and Education: Equip your team with templates and procedures to adapt to the updated requirements effectively.
For more insights, refer to these key resources:
Conclusion
September 2024 FDA Guidance on Chemical Analysis
The FDA’s 2024 guidance on chemical analysis for biocompatibility assessments marks a significant step forward in ensuring the safety of medical devices.
While the new requirements present challenges, they also provide opportunities for improving patient safety and regulatory compliance. By adopting proactive strategies and leveraging expert support, manufacturers can navigate these changes effectively and maintain their competitive edge.
For personalized support, contact CLIN-r+ or schedule a consultation:
