[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79615-79617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22309]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-4168; FDA-2024-D-4169; FDA-2024-D-4170; and FDA-
2024-D-4171]
Safety and Performance Based Pathway Device-Specific Guidances;
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 four final device-specific guidance documents for
the Safety and Performance Based Pathway--specifically, ``Air Powered
Dental Handpieces and Air Motors--Performance Criteria for Safety and
[[Page 79616]]
Performance Based Pathway,'' ``Dental Ceramics--Performance Criteria
for Safety and Performance Based Pathway,'' ``Dental Impression
Materials--Performance Criteria for Safety and Performance Based
Pathway,'' and ``Dental Cements--Performance Criteria for Safety and
Performance Based Pathway.'' The device-specific guidances identified
in this notice were developed in accordance with the finalized guidance
entitled ``Safety and Performance Based Pathway.''
DATES: The announcement of the guidances is published in the Federal
Register on September 30, 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-2024-D-4168 for ``Air Powered Dental Handpieces and Air Motors--
Performance Criteria for Safety and Performance Based Pathway,'' Docket
No. FDA-2024-D-4169 for ``Dental Ceramics--Performance Criteria for
Safety and Performance Based Pathway,'' Docket No. FDA-2024-D-4170 for
``Dental Impression Materials--Performance Criteria for Safety and
Performance Based Pathway,'' or Docket No. FDA-2024-D-4171 for ``Dental
Cements--Performance Criteria for Safety and Performance Based
Pathway.'' 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 documents are available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidances. Submit written
requests for a single hard copy of the guidance document entitled ``Air
Powered Dental Handpieces and Air Motors--Performance Criteria for
Safety and Performance Based Pathway,'' ``Dental Ceramics--Performance
Criteria for Safety and Performance Based Pathway,'' ``Dental
Impression Materials--Performance Criteria for Safety and Performance
Based Pathway,'' or ``Dental Cements--Performance Criteria for Safety
and Performance Based Pathway'' 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: Jason Ryans, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, 301-796-4908.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of four final device-specific
guidance documents for the Safety and Performance Based Pathway--
specifically, ``Air Powered Dental Handpieces and Air Motors--
Performance Criteria for Safety and Performance Based Pathway,''
``Dental Ceramics--Performance Criteria for Safety and Performance
Based Pathway,'' ``Dental Impression Materials--Performance Criteria
for Safety and Performance Based Pathway,'' and ``Dental Cements--
Performance Criteria for Safety and Performance Based Pathway.'' These
device-specific guidance documents provide performance criteria for
premarket notification (510(k)) submissions to support the optional
Safety and Performance Based Pathway, as described in the guidance
entitled ``Safety and Performance Based Pathway.'' \1\ As described in
that guidance, substantial equivalence is
[[Page 79617]]
rooted in comparisons between new devices and predicate devices.
However, the Federal Food, Drug, and Cosmetic Act (FD&C Act) does not
preclude FDA from using performance criteria to facilitate this
comparison. If a legally marketed device performs at certain levels
relevant to its safety and effectiveness, and a new device meets those
levels of performance for the same characteristics, FDA could find the
new device as safe and effective as the legally marketed device.
Instead of reviewing data from direct comparison testing between the
two devices, FDA could support a finding of substantial equivalence
with data demonstrating the new device meets the level of performance
of an appropriate predicate device(s). Under this optional Safety and
Performance Based Pathway, a submitter of air powered dental handpieces
and air motors, or dental cement devices could satisfy the requirement
to compare its device with a legally marketed device by, among other
things, independently demonstrating that the device's performance meets
performance criteria as established in the relevant above-listed
guidance rather than using direct predicate comparison testing for some
of the performance characteristics.
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\1\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway.
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These guidances are being implemented without prior public comment
because the Agency has determined that prior public participation is
not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act
(21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). FDA has determined
that these guidance documents present less burdensome policies that are
consistent with public health. Although these guidances are being
implemented immediately, FDA will consider all comments received and
revise the guidance documents as appropriate.
These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These guidances
represent the current thinking of FDA on ``Air Powered Dental
Handpieces and Air Motors--Performance Criteria for Safety and
Performance Based Pathway,'' ``Dental Ceramics--Performance Criteria
for Safety and Performance Based Pathway,'' ``Dental Impression
Materials--Performance Criteria for Safety and Performance Based
Pathway,'' and ``Dental Cements--Performance Criteria for Safety and
Performance Based Pathway.'' 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 a copy of the 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. These guidance documents are
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 ``Air Powered Dental Handpieces and Air
Motors--Performance Criteria for Safety and Performance Based
Pathway,'' ``Dental Ceramics--Performance Criteria for Safety and
Performance Based Pathway,'' ``Dental Impression Materials--Performance
Criteria for Safety and Performance Based Pathway,'' or ``Dental
Cements--Performance Criteria for Safety and Performance Based
Pathway'' may send an email request to [email protected] to
receive an electronic copy of the document. Please use the document
number GUI00021014 for ``Air Powered Dental Handpieces and Air Motors--
Performance Criteria for Safety and Performance Based Pathway,''
document number GUI00007014 for ``Dental Ceramics--Performance Criteria
for Safety and Performance Based Pathway,'' document number GUI00007013
for ``Dental Impression Materials--Performance Criteria for Safety and
Performance Based Pathway,'' or document number GUI00021005 for
``Dental Cements--Performance Criteria for Safety and Performance Based
Pathway'' 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; guidance Topic No.
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807, subpart E...................... Premarket 0910-0120
notification.
``Requests for Feedback and Meetings Q-submissions; pre- 0910-0756
for Medical Device Submissions: The submissions.
Q-Submission Program''.
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Dated: September 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22309 Filed 9-27-24; 8:45 am]
BILLING CODE 4164-01-P