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# ISO 10993-1 Clarifying Guidance
- URL: https://www.fdaweb.com/iso-10993-1-clarifying-guidance/
- Published: 2023-09-07T12:00:00.000Z
- Updated: 2026-09-14T18:54:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155265

FDA has published a guidance, *Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices—Part I: Evaluation and Testing Within a Risk Management Process*, to provide further clarification and updated information on using the designated ISO standard to support applications to FDA. The agency says the [document](https://www.fda.gov/media/142959/download?ref=fdaweb.com) is to assist the medical device industry in preparing PMAs, HDEs, IDEs, 510(k)s, and *de novo* requests for medical devices that come into direct or indirect contact with the human body. The guidance also incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and devices made from *in situ* polymerizing and/or absorbable materials, FDA says.

The guidance contains an Introduction, Scope, Risk Management for Biocompatibility Evaluations, ISO 10993—Part I and the FDA-Modified Matrix, General Biocompatibility Testing Conditions, Test-Specific Considerations, Chemical Assessment, Labeling Devices as “-Free,” and six attachments.