FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ANIMAL STUDIES FOR DENTAL BONE GRAFTING MATERIAL DEVICES-PREMARKET NOTIFICATION (510(K)) SUBMISSIONS; GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, Aug. 22 -- Food and Drug Administration has issued a notice called: Animal Studies for Dental Bone Grafting Material Devices-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on Aug. 22 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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 s...