[Federal Register Volume 89, Number 62 (Friday, March 29, 2024)]
[Notices]
[Pages 22160-22162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06734]


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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Premarket Notification (510(k)) Submissions; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Animal Studies for 
Dental Bone Grafting Material Devices--Premarket Notification (510(k)) 
Submissions.'' This draft guidance document provides animal study 
design recommendations and animal study information to include to 
support a 510(k) submission for dental bone grafting material devices. 
This draft guidance may help manufacturers comply with some special 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. This 
draft guidance is not final nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by May 28, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and

[[Page 22161]]

Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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 draft 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. 5431, 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 draft 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 draft 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 implantation (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.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 draft 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 [email protected] 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:

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                                                            OMB control
    21 CFR part or guidance               Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120

[[Page 22162]]

 
``Requests for Feedback and      Q-submissions and Early       0910-0756
 Meetings for Medical Device      Payor Feedback Request
 Submissions: The Q-Submission    Programs for Medical
 Program''.                       Devices.
58.............................  Good Laboratory               0910-0119
                                  Practice (GLP)
                                  Regulations for
                                  Nonclinical Laboratory
                                  Studies.
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    Dated: March 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06734 Filed 3-28-24; 8:45 am]
BILLING CODE 4164-01-P