Devices

Biological Evaluation of Medical Devices Guidance

FDA has posted a final guidance entitled Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process. The document is intended to provide further clarification and updated information on the ISO standard to support applications submitted to FDA. It also 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 previous guidance from the agency.

“When assessing new devices,” FDA says, “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. 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.”

The guidance explains that 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 change impact. “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,” it says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome