[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:
    <bullet> 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.
    <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-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.
    <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 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 <a href="/cdn-cgi/l/email-protection#8dcec9dfc5a0caf8e4e9ece3eee8cdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="bffcfbedf792f8cad6dbded1dcdaffd9dbde91d7d7cc91d8d0c9">[email protected]</span></a> 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


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