GUIDANCE DOCUMENT
Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions Draft Guidance for Industry and Food and Drug Administration Staff March 2024
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2024-D-1242
- Docket Number:
- FDA-2024-D-1242
- Issued by:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance document provides the FDA's recommendations on animal studies to support premarket notification (510(k)) submissions for dental bone grafting material devices. The recommendations may assist manufacturers in complying with some special controls for these devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of dental bone grafting material device submissions.