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# Medical Device Biocompatibility Guidance
- URL: https://www.fdaweb.com/medical-device-biocompatibility-guidance/
- Published: 2024-09-19T12:00:00.000Z
- Updated: 2026-09-14T14:41:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157811

FDA has published a draft guidance, *Chemical Analysis for Biocompatibility Assessment of Medical Devices*, describing recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chemical-analysis-biocompatibility-assessment-medical-devices?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the recommendations are intended to improve the consistency and reliability of analytical chemistry studies and are based on FDA’s experiences evaluating such studies submitted as part of premarket submissions to demonstrate device biocompatibility. However, it says, alternative approaches to conducting chemical characterization may be appropriate.

The draft contains an Introduction, Background, Scope, Information Gathering, Test Article Extraction, Chemical Analysis, Data Reporting, and 4 Appendices.