Notice2024-15337
Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
July 12, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances entitled "Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions" and "Dental Curing Lights--Premarket Notification (510(k)) Submissions." These draft guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices and dental curing lights. When final, these guidances will supersede the guidances "Dental Composite Resin Devices--Premarket Notification [510(k)] Submissions" dated October 26, 2005 and "Dental Curing Lights-- Premarket Notification [510(k)] Submissions" dated March 27, 2006. The recommendations in these draft guidances are intended to promote consistency and facilitate efficient review of these submissions. These draft guidances are not final nor are they for implementation at this time.
Full Text
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<title>Federal Register, Volume 89 Issue 134 (Friday, July 12, 2024)</title>
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[Federal Register Volume 89, Number 134 (Friday, July 12, 2024)]
[Notices]
[Pages 57155-57157]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15337]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2024-D-2511 and FDA-2024-D-2512]
Dental Composite Resin Devices and Dental Curing Lights--
Premarket Notification (510(k)) Submissions Guidances; Draft Guidances
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 two draft guidances entitled ``Dental Composite
Resin Devices--Premarket Notification (510(k)) Submissions'' and
``Dental Curing Lights--Premarket Notification (510(k)) Submissions.''
These draft guidance documents provide recommendations for device
description, performance testing, and labeling to include in 510(k)
submissions for dental composite resin devices and dental curing
lights. When final, these guidances will supersede the guidances
``Dental Composite Resin Devices--Premarket Notification [510(k)]
Submissions'' dated October 26, 2005 and ``Dental Curing Lights--
Premarket Notification [510(k)] Submissions'' dated March 27, 2006. The
recommendations in these draft guidances are intended to promote
consistency and facilitate efficient review of these submissions. These
draft guidances are not final nor are they for implementation at this
time.
[[Page 57156]]
DATES: Submit either electronic or written comments on the draft
guidance by September 10, 2024 to ensure that the Agency considers your
comment on the 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2511 for ``Dental Composite Resin Devices--Premarket
Notification (510(k)) Submissions'' or the Docket No. FDA-2024-D-2512
for ``Dental Curing Lights--Premarket Notification (510(k))
Submissions.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
``Dental Composite Resin Devices--Premarket Notification (510(k))
Submissions'' or ``Dental Curing Lights--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: Michael Adjodha, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G304, Silver Spring, MD 20993-0002, 301-
796-6276.
SUPPLEMENTARY INFORMATION:
I. Background
These draft guidance documents provide recommendations for device
description, performance testing, and labeling to include in 510(k)
submissions for dental composite resin devices and dental curing
lights. Dental composite resin devices are devices intended to fill and
restore defects or carious lesions in teeth. The device may be supplied
as a two-part base and catalyst system that is self-cured or a one-part
system that is cured via photoinitiation. Dental curing lights are
devices that emit non-ionizing optical radiation intended to
photopolymerize dental restorative resins. These guidances, when final,
will supersede ``Dental Composite Resin Devices--Premarket Notification
[510(k)] Submissions'' dated October 26, 2005 and ``Dental Curing
Lights--Premarket Notification [510(k)] Submissions'' dated March 27,
2006. The recommendations in these draft guidances are intended to
promote consistency and facilitate efficient review of these
submissions.
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on Dental
Composite Resin Devices--Premarket Notification (510(k)) Submissions
and Dental Curing Lights--Premarket Notification (510(k)) Submissions.
They do not establish any rights for any person and are 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 copies of the draft guidances 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. These guidance documents are
also available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and
[[Page 57157]]
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to download an electronic copy of ``Dental
Composite Resin Devices--Premarket Notification (510(k)) Submissions
(document number GUI00016050)'' or ``Dental Curing Lights--Premarket
Notification (510(k)) Submissions (document number GUI00016017)'' may
send an email request to <a href="/cdn-cgi/l/email-protection#5e1d1a0c1673192b373a3f303d3b1e383a3f7036362d70393128"><span class="__cf_email__" data-cfemail="94d7d0c6dcb9d3e1fdf0f5faf7f1d4f2f0f5bafcfce7baf3fbe2">[email protected]</span></a> to receive an
electronic copy of the document. Please use the document number and
complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While these guidances contain no new collection of information,
they do 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
812............................ Investigational Device 0910-0078
Exemption.
``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.
800, 801, 809, and 830......... Medical Device Labeling 0910-0485
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.
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Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15337 Filed 7-11-24; 8:45 am]
BILLING CODE 4164-01-P
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