FDA Drafts Guidance for Dental Bone Grafting Studies

The FDA has provided draft guidance concerning its recommendations related to animal studies used to support premarket notification (510(k)) submissions for certain Class II dental bone grafting material devices (devices intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region).

What is in the guidance?

This draft guidance contains 50 detailed animal study recommendations to assist manufacturers in providing sufficient animal study data required to support their 501(k) submission for dental bone grafting material devices.

You can read the full draft guidance from the FDA here.

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If you have questions about the new draft guidance, or need help with your 510(k) submission, please don’t hesitate to contact us.

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