🦷FDA Guidance on Animal Studies for Dental Bone Grafting Devices
Animal Studies for Dental Bone Grafting Material Devices-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The guidance outlines compliance requirements for manufacturers of dental bone grafting material devices, specifically detailing animal study designs necessary for 510(k) submissions. This encourages businesses to align their product development with FDA recommendations to avoid regulatory hurdles.