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FDA Issues Final Guidance for Use of ISO 10993-1 for Medical Devices

The document provides further clarification and updated information on the use of International Standard ISO 10993–1, “Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process.”

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The FDA has announced the availability of 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 guidance incorporates updates to the FDA’s current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. The Center for Devices and Radiological Health (CDRH) will host a webinar on Oct. 12, 2023 for industry members and others interested in learning more about the guidance.

The purpose of the guidance is to provide further clarification and updated information on the use of International Standard ISO 10993–1, to support premarket approval applications (PMAs), humanitarian device exemptions (HDEs), investigational device exemption (IDE) applications, premarket notifications (510(k)s), and De Novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body.

The guidance adds, within a new attachment (Attachment G), recommendations which reflect the agency’s current thinking about the type of biocompatibility information that should be provided in a medical device premarket submission for certain devices in contact with intact skin. It incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, 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, and biocompatibility recommendations when certain materials only contact intact skin.

To submit an electronic comment, including any attachments, go to https://www.regulations.gov.


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