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Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions. This guidance provides proposed recommendations on animal studies for dental bone grafting material devices consistent with current review practices.
Facts about the draft guidance
This draft guidance, when finalized, is intended to:
- Provide recommendations for animal studies that may assist manufacturers in complying with some special controls for dental bone grafting material devices.
- Provide recommendations for manufacturers who choose to combine an animal study with the biocompatibility evaluation of implantation (or the local effects after implantation) for these devices.
- Augment the recommendations provided in the Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.
- Promote consistency and facilitate efficient review of submissions for these dental bone grafting material devices.
Note: This guidance is not for implementation at this time.
Submit comments on this draft guidance
Submit comments under docket number FDA-2024-D-1242 at regulations.gov by May 28, 2024 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?
If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.
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