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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Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions Draft Guidance for Industry and Food and Drug Administration Staff March 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-1242
Issued by:
Guidance Issuing Office
Center 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This draft guidance document provides the FDA's recommendations on animal studies to support premarket notification (510(k)) submissions for dental bone grafting material devices.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.

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

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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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