[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4307-4309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-5430]


Characterization of Metallic Coatings and/or Calcium Phosphate 
Coatings on Orthopedic Devices; Draft Guidance for Industry and Food 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the availability of the draft guidance entitled ``Characterization of 
Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic 
Devices.'' This draft guidance document provides recommendations for 
premarket submissions for orthopedic devices that contain metallic 
coatings and/or calcium phosphate coatings on the surface. This draft 
guidance is not final nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by March 25, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

[[Page 4308]]

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-5430 for ``Characterization of Metallic Coatings and/or 
Calcium Phosphate Coatings on Orthopedic Devices.'' 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 
``Characterization of Metallic Coatings and/or Calcium Phosphate 
Coatings on Orthopedic Devices'' 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: Limin Sun, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4430, Silver Spring, MD 20993-0002, 301-796-7056.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document provides recommendations for premarket 
submissions for orthopedic devices that contain metallic coatings and/
or calcium phosphate coatings on the surface. The recommendations in 
this document are applicable to class II and class III devices intended 
for orthopedic applications that contain metallic and/or calcium 
phosphate coatings. Specifically, this draft guidance addresses the 
characterization of the following coatings on orthopedic devices: (1) a 
metallic coating, which can be manufactured using thermal spray (e.g., 
plasma spray), sintering (e.g., sintering of powders, beads, or fiber 
mesh pad), chemical vapor deposition/infiltration, physical vapor 
deposition (e.g., ionic plasma deposition), additive manufacturing 
(e.g., electron beam manufacturing, selective laser sintering), or 
other methods; (2) a calcium phosphate coating, which can be 
manufactured by plasma spray, solution precipitation, electrochemical 
deposition, or other methods; and (3) a metallic and calcium phosphate 
dual coating, which can be manufactured using one or more of the above 
methods.
    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 
``Characterization of Metallic Coatings and/or Calcium Phosphate 
Coatings on Orthopedic Devices.'' 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 ``Characterization of Metallic Coatings 
and/or Calcium Phosphate Coatings on Orthopedic Devices'' may send an 
email request to [email protected] to receive

[[Page 4309]]

an electronic copy of the document. Please use the document number 
GUI00020051 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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    21 CFR part or guidance             Topic           OMB control No.
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807, subpart E................  Premarket                      0910-0120
                                 notification.
814, subparts A through E.....  Premarket approval...          0910-0231
812...........................  Investigational                0910-0078
                                 Device Exemption.
``Requests for Feedback and     Q-submissions and              0910-0756
 Meetings for Medical Device     Early Payor Feedback
 Submissions: The Q-Submission   Request Programs for
 Program''.                      Medical Devices.
800, 801, 809 and 830.........  Medical Device                 0910-0485
                                 Labeling
                                 Regulations; Unique
                                 Device
                                 Identification.
58............................  Good Laboratory                0910-0119
                                 Practice (GLP)
                                 Regulations for
                                 Nonclinical
                                 Laboratory Studies.
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    Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01158 Filed 1-22-24; 8:45 am]
BILLING CODE 4164-01-P