Notice2025-16137
Animal Studies for Dental Bone Grafting Material Devices-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 22, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 161 (Friday, August 22, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 161 (Friday, August 22, 2025)]
[Notices]
[Pages 41078-41080]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16137]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-1242]
Animal Studies for Dental Bone Grafting Material Devices--
Premarket Notification (510(k)) Submissions; Guidance for Industry and
Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of 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.
DATES: The announcement of the guidance is published in the Federal
Register on August 22, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
[[Page 41079]]
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-D-1242 for ``Animal Studies for Dental Bone Grafting Material
Devices--Premarket Notification (510(k)) Submissions.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Animal Studies for Dental Bone Grafting Material Devices--Premarket
Notification (510(k)) Submissions'' to the Office of Policy, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
FOR FURTHER INFORMATION CONTACT: Joel Anderson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G234, Silver Spring, MD 20993-0002, 301-796-6520.
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''
(<a href="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">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</a>), 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
[[Page 41080]]
Health guidance documents is available at <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This
guidance document is also available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#f8bbbcaab0d5bf8d919c99969b9db89e9c99d690908bd69f978e"><span class="__cf_email__" data-cfemail="edaea9bfa5c0aa9884898c838e88ad8b898cc385859ec38a829b">[email protected]</span></a> 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 0910-0120
notification.
``Requests for Feedback and Q-submissions and 0910-0756
Meetings for Medical Device Early Payor
Submissions: The Q-Submission Feedback Request
Program''. Programs for
Medical Devices.
58............................. Good Laboratory 0910-0119
Practice (GLP)
Regulations for
Nonclinical
Laboratory Studies.
------------------------------------------------------------------------
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16137 Filed 8-21-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 22, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.