FDA Issues Draft Guidance For Medical Device Biocompatibility

Agency currently collecting comments on methods for testing and documenting medical device biocompatibility

The Food and Drug Administration released a draft guidance document for medical device manufacturers and FDA staff titled "Chemical Analysis for Biocompatibility Assessment of Medical Devices." The document provides detailed recommendations that expand on the FDA-recognized consensus chemical characterization standard, ISO 10993-18:2020. With these recommendations, the guidance aims to improve the consistency and reliability of chemical analysis for biocompatibility assessments by addressing more specific considerations for information gathering, test article extraction, chemical analysis, and data reporting.