```

[Federal Register Volume 89, Number 226 (Friday, November 22, 2024)]
[Notices]
[Pages 92691-92692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27114]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0488]

Orthopedic Non-Spinal Bone Plates, Screws, and Washers--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 ``Orthopedic Non-Spinal 
Bone Plates, Screws, and Washers--Premarket Notification (510(k)) 
Submissions.'' This guidance document provides recommendations for 
information to include in 510(k) submissions for non-resorbable bone 
plate, screw, and washer devices. The scope of this guidance includes 
devices that are indicated for orthopedic bone fixation but does not 
include devices indicated for spinal, mandibular, maxillofacial, 
cranial, and orbital fracture fixation.

DATES: The announcement of the guidance is published in the Federal 
Register on November 22, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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 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-2023-D-0488 for ``Orthopedic Non-Spinal Bone Plates, Screws, and 
Washers--Premarket Notification (510(k)) Submissions; Guidance for 
Industry and Food and Drug Administration Staff.'' 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 guidance document entitled 
``Orthopedic Non-Spinal Bone Plates, Screws, and Washers--Premarket 
Notification (510(k)) Submissions; Guidance for

[[Page 92692]]

Industry and Food and Drug Administration Staff'' 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: Mahlet Zinah, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4452, Silver Spring, MD 20993-0002, 240-402-2623.

SUPPLEMENTARY INFORMATION:

I. Background

    Non-spinal, non-resorbable bone plates, screws, and washers are 
implants intended for bone fixation. These are class II medical devices 
for which the safety and effectiveness are well-established. This 
guidance provides recommendations for the content and organization of 
premarket notification (510(k)) submissions including the information 
FDA recommends industry include in a 510(k) submission for these device 
types (e.g., non-clinical testing, sterility, reprocessing, 
biocompatibility). This guidance is intended to facilitate consistency 
in information provided in submissions by addressing common 
deficiencies related to device description and performance testing and 
by identifying applicable cross-cutting guidances and consensus 
standards.
    A notice of availability of the draft guidance appeared in the 
Federal Register of March 29, 2023 (88 FR 18549). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including clarification regarding recommended language 
for indications for use statements as well as additional considerations 
for predicate device comparisons when leveraging information from 
previously cleared devices.
    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 ``Non-Spinal Bone Plates, Screws, and 
Washers--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 ``Non-Spinal Bone Plates, Screws, and 
Washers--Premarket Notification (510(k)) Submissions; Guidance for 
Industry and Food and Drug Administration Staff'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number GUI00019023 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:

------------------------------------------------------------------------
                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``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.
800, 801, 809, and 830............  Medical Device             0910-0485
                                     Labeling
                                     Regulations; Unique
                                     Device
                                     Identification.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
50, 56............................  Protection of Human        0910-0130
                                     Subjects and
                                     Institutional
                                     Review Boards.
------------------------------------------------------------------------

    Dated: November 12, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-27114 Filed 11-21-24; 8:45 am]
BILLING CODE 4164-01-P
```