Biocompatibility & TRA Toolkit
Biological evaluation plan, toxicological risk assessment, chemical characterization report structure, test selection justification, BER summary, and FDA submission checklist — the complete ISO 10993 documentation package.
What You Get
Biological Evaluation Plan Template (ISO 10993-1:2018)
Complete biological evaluation plan aligned with ISO 10993-1:2018 and FDA's 2023 Use of ISO 10993-1 guidance. Covers device description and material characterization, patient contact nature and duration, applicable biological evaluation endpoints per Table A.1, existing data assessment, and the testing decision framework that determines when new testing is required versus when chemical characterization or literature review is sufficient.
Toxicological Risk Assessment (TRA) Report Template
Structured TRA report template aligned with ISO 10993-17 and FDA biocompatibility expectations. Covers chemical characterization data integration, toxicological threshold methodology, tolerable intake calculations, analytical chemistry data interpretation, and the margin of safety analysis that FDA reviewers use to evaluate whether testing gaps are acceptable.
Chemical Characterization Report Structure Template (ISO 10993-18)
Framework for chemical characterization reports per ISO 10993-18:2020. Covers extraction study design, analytical method selection, analytical threshold (AT) and qualification threshold (QT) application, identified chemical reporting format, and the report structure for integration into a biological evaluation as an alternative to traditional biocompatibility testing.
Biocompatibility Test Selection Justification Template
Template for documenting test selection rationale per ISO 10993-1 Table A.1. For each applicable endpoint: contact nature and duration classification, existing data assessment, testing decision (test required, exempt, or addressed by alternative means), justification for any exemptions, and the referenced test standard when testing is required. Structured for FDA submission as part of a 510k or PMA.
Biological Evaluation Report (BER) Summary Template
Final biological evaluation report summary template integrating all evaluation components. Covers device and material description, contact classification, evaluation approach summary, testing and alternative method results, overall biocompatibility conclusions, and the residual risk acceptability statement. Formatted for both FDA submission and ISO 13485 technical file inclusion.
FDA Biocompatibility Submission Checklist (510k and PMA)
Submission checklist covering FDA biocompatibility documentation requirements for 510k and PMA applications. Covers the biocompatibility summary section structure, test report requirements, chemical characterization acceptance criteria, ISO 10993 edition considerations, and the FDA reviewer expectations for each device contact category that most commonly generate additional information (AI) requests.
FAQ
When can chemical characterization replace biocompatibility testing?
When chemical characterization demonstrates that extractables are below the analytical threshold (AT) or can be risk-assessed using TRA to be below the tolerable intake (TI), testing for that endpoint may not be required. FDA's 2023 guidance provides the framework for this determination.
Which ISO 10993 edition does FDA currently accept?
FDA's 2023 guidance on Use of ISO 10993-1 aligns with the 2018 edition. FDA accepts both the testing approach and the chemical characterization plus TRA approach for demonstrating biocompatibility.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use in your biological evaluation file.
Ready to get started?
For informational purposes only. Not legal or regulatory advice. Legal