[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Coatings on Orthopedic Devices; Draft Guidance for Industry and Food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the availability of the draft guidance entitled ``Characterization of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 This draft guidance document provides recommendations for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 This draft
guidance is not final nor is it for implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by March 25, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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]
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