[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41967-41969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13730]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-2370]


Patient-Matched Guides to Orthopedic Implants; Draft Guidance for 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the availability of the draft guidance entitled ``Patient-Matched 
Guides to Orthopedic Implants.'' This draft guidance document provides 
recommendations regarding information that should be included in 
regulatory submissions for patient-matched guides to orthopedic 
implants. This draft guidance also provides recommendations that 
manufacturers should consider when developing their design process for 
these device types.

[[Page 41968]]

This draft guidance is intended to promote clarity and transparency as 
to expectations regarding submission recommendations for orthopedic 
patient-matched guides. Following such recommendations may increase 
efficiency and consistency in review. This draft guidance is not final 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DATES: Submit either electronic or written comments on the draft 
guidance by August 28, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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-2370 for ``Patient-Matched Guides to Orthopedic Implants.'' 
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 
``Patient-Matched Guides to Orthopedic Implants'' 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: Michel Janda, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4428, Silver Spring, MD 20993-0002, 301-796-6395.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Patient-Matched Guides to Orthopedic 
Implants.'' FDA has developed this guidance document for members of 
industry who submit and FDA staff who review premarket submissions for 
patient-matched guides for orthopedic implants. Patient-matched guides 
are intended to assist in the execution of a pre-surgical plan 
concurred upon by the patient's healthcare professional to position an 
orthopedic implant in a way consistent with the implant's indicated 
use. This draft guidance is intended to promote clarity and 
transparency as to expectations regarding submission recommendations 
for orthopedic patient-matched guides. Following such recommendations 
may increase efficiency and consistency in review. Additionally, this 
draft guidance provides recommended best practices regarding certain 
elements of the design process.
    This draft guidance was part of the 2015 initiative to incorporate 
stakeholder feedback during guidance development (80 FR 1424, January 
9, 2015) available at https://www.federalregister.gov/documents/2015/01/09/2015-00115/medical-device-user-fee-and-modernization-act-notice-to-public-of-website-location-of-fiscal-year. Specific questions were 
posed to solicit input into the context of the guidance and comments 
were collected through Docket No. FDA-2012-N-1021.
    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 ``Patient-
Matched Guides to Orthopedic Implants.'' 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.

[[Page 41969]]

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 or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Patient-Matched Guides to Orthopedic 
Implants'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number GUI01400006 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. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations, guidance, and forms 
have been approved by OMB as listed in the following table:

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          21 CFR Part                   Topic           OMB Control No.
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807, subpart E................  Premarket                      0910-0120
                                 notification.
820...........................  Current Good                   0910-0073
                                 Manufacturing
                                 Practice (CGMP);
                                 Quality System (QS)
                                 Regulation.
812...........................  Investigational                0910-0078
                                 Device Exemption.
814, subparts A through E.....  Premarket approval...          0910-0231
800, 801, and 809.............  Medical Device                 0910-0485
                                 Labeling Regulations.
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    Dated: June 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13730 Filed 6-27-23; 8:45 am]
BILLING CODE 4164-01-P


