This resource is the guidance document “Chemical Analysis for Biocompatibility Assessment of Medical Devices” published by the US FDA (Food and Drug Administration), which guides companies on using chemical characterisation to support biocompatibility evaluation.
About this document
The guidance sets out the FDA’s expectations for extractables and leachables (E&L) studies, including selection of extraction conditions, analytical methods, the analytical evaluation threshold (AET), data reporting, and how to use chemical analysis results in toxicological risk assessment, alongside ISO 10993-18 and ISO 10993-17.
Applicable products and users
- Medical devices in direct or indirect contact with the human body, especially long-term contact or implantable devices
- Companies preparing 510(k), De Novo or PMA submissions that need chemical characterisation to replace or supplement some biological tests
Main contents
- Selection of test conditions such as extraction solvent, temperature and time
- Qualitative and quantitative analytical methods for extractables / leachables
- Calculation of the analytical evaluation threshold (AET) and uncertainty
- What a chemical analysis report should contain and common deficiencies
Download
Related articles
- FDA: The Complete Compliance Path for Biocompatibility Submissions for Medical Devices
- US FDA Medical Device Registration Services
Need help interpreting this document or assessing its impact on your product? EVERBIZ provides regulatory consulting and registration services – please contact us.
Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.