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# FDA Guidance on Device Biological Evaluations
- URL: https://www.fdaweb.com/fda-guidance-on-device-biological-evaluations/
- Published: 2016-06-15T12:00:00.000Z
- Updated: 2026-09-14T21:09:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135950

FDA has posted a [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM348890.pdf?ref=fdaweb.com) on “Use of International Standard ISO 10993-1 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.” The agency says the document is intended to assist industry in preparing marketing submissions for medical devices that come into direct or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from such contact. It provides further clarification and updated information on using International Standard ISO 10993-1 to support applications to FDA.

FDA says the guidance replaces Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.’” It also says the document incorporates several new 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 for devices made from in situ polymerizing and/or absorbable materials, which were not previously discussed in G95-1.

“When assessing new devices, the sponsor should specifically state if the device does not have any direct or indirect tissue contact, and no further biocompatibility information would be needed,” the guidance says. “When assessing device modifications, the sponsor should specifically state if the modification does not result in a change to any direct or indirect tissue-contacting components, and no further biocompatibility information would typically be needed. However, if the change could affect other parts of the device with direct or indirect contact that were not changed, a biocompatibility evaluation should be conducted to assess the potential impact of the change. For example, if a new non-contact internal component is added, but it requires the application of heat in order to join to another component that has patient contact, the patient-contacting component may be impacted by the application of heat such that biocompatibility could be impacted, and should be assessed.”