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Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.”
This guidance was revised to add recommendations that were described in the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. The final guidance reflects the FDA'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 (see Attachment G of the guidance).
Attachment G of this final guidance describes:
- Recommendations for certain medical devices made from common materials that are in contact with intact skin. The materials in the scope of Attachment G are listed and include polymers, such as plastics or silicone, and fabrics, such as cotton or rayon.
- Approaches that sponsors can use to decide when the policy in Attachment G is applicable.
- What kind of information and labeling the FDA recommends including in a premarket submission.
- How manufacturers can use a quality management system and post-market strategies, including purchasing and manufacturing process controls and customer complaint review, to identify biocompatibility issues.
This final guidance also includes other minor updates, such as revisions to align with current versions of recognized consensus standards.
Upcoming webinar on this guidance
On October 12, 2023, the FDA will host a webinar for industry and others interested in learning more about the guidance.
Questions?
Visit the Biocompatibility Assessment Resource Center for more information.
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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