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GUIDANCE DOCUMENT

Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff August 2025

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2024-D-1242
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This 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 guidance also provides recommendations that may aid in the reduction of the total number of animals used to support a submission, supports the 3Rs of replace, reduce and/or refine animal use, and encourages manufacturers to consult FDA if they wish to use a non-animal testing method they believe is suitable. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of dental bone grafting material device submissions.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-1242.

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