Notice 22 Aug 2025 regulatory compliance, healthcare, fda, medical devices, dental, premarket notification, animal studies

🦷FDA Guidance on Animal Studies for Dental Bone Grafting Devices

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Animal Studies for Dental Bone Grafting Material Devices--Premarket Notification (510(k)) Submissions." This guidance document provides recommendations for animal study design and animal study information to include to support a 510(k) submission for dental bone grafting material devices. This guidance may help manufacturers comply with some special controls for dental bone grafting material devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions.

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