Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2025-16137 · Docket No. FDA-2024-D-1242

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.

Dates

The announcement of the guidance is published in the Federal Register on August 22, 2025.

Supplementary Information

I. Background A dental bone grafting material device is a material that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. This guidance document provides premarket notification (510(k)) submission recommendations for animal studies that may help manufacturers comply with the in vivo performance special control identified in FDA's guidance, “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices” ( https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/dental-bone-grafting-material-devices-class-ii-special-controls-guidance-industry-and-fda-staff ), for dental bone grafting material devices. This guidance document also provides recommendations for manufacturers who choose to combine an animal study that evaluates in vivo safety and performance of the dental bone grafting material with a biocompatibility evaluation of the implantation endpoint (or the local effects after implantation) to help reduce the total number of animals used to support the 510(k) submission. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions. A notice of availability of the draft guidance appeared in the Federal Register of March 29, 2024 (89 FR 22160). FDA considered comments received and revised the guidance as appropriate in response to the comments, including minor clarifications to the animal study design recommendations for the evaluation of dental bone grafting material devices and providing additional reference citations. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Animal Studies for Dental Bone Grafting Material Devices—Premarket Notification (510(k)) Submissions.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of “Animal Studies for Dental Bone Grafting Material Devices—Premarket Notification (510(k)) Submissions” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00007042 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB: 21 CFR part or guidance Topic OMB control No. 807, subpart E Premarket notification 0910-0120 “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” Q-submissions and Early Payor Feedback Request Programs for Medical Devices 0910-0756 58 Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies 0910-0119 Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-16137 Filed 8-21-25; 8:45 am]