Endosseous Dental Implants and Endosseous Dental Implant Abutments-Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability, 83019-83020 [2024-23716]

Download as PDF Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices Food and Drug Administration public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). [Docket No. FDA–2024–D–4409] Written/Paper Submissions Endosseous Dental Implants and Endosseous Dental Implant Abutments—Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability 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–4409 for ‘‘Endosseous Dental Implants and Endosseous Dental Implant Abutments—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:// DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Endosseous Dental Implants and Endosseous Dental Implant Abutments—Performance Criteria for Safety and Performance Based Pathway.’’ The device-specific guidance identified in this notice was developed in accordance with the finalized guidance entitled ‘‘Safety and Performance Based Pathway.’’ This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency’s good guidance practices. DATES: The announcement of the guidance is published in the Federal Register on October 15, 2024. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: 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 VerDate Sep<11>2014 16:35 Oct 11, 2024 Jkt 265001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 83019 www.govinfo.gov/content/pkg/FR-201509-18/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 guidance document entitled ‘‘Endosseous Dental Implants and Endosseous Dental Implant Abutments—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 The Agency is announcing the availability of the final guidance document ‘‘Endosseous Dental Implants and Endosseous Dental Implant Abutments—Performance Criteria for Safety and Performance Based Pathway.’’ This device-specific guidance document provides 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 rooted in comparisons between new devices and predicate devices. However, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) does not preclude FDA from using performance 1 Available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ safety-and-performance-based-pathway. E:\FR\FM\15OCN1.SGM 15OCN1 83020 Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 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 an endosseous implant and endosseous implant abutment device 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. This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act (21 U.S.C. II. Electronic Access Persons interested in obtaining a copy of the 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is 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 ‘‘Endosseous Dental Implants and Endosseous Dental Implant Abutments—Performance Criteria for Safety and Performance Based Pathway’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00021017 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 (44 U.S.C. 3501– 3521). The collections of information in the following table have been approved by OMB: OMB Control No. 21 CFR part; guidance; or FDA form Topic 807, subpart E ............................................................................ ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’. Premarket notification ................................................................. Q-submissions and Early Payor Feedback Request Programs for Medical Devices. Dated: October 4, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024–23716 Filed 10–11–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0026] Issuance of Priority Review Voucher; Rare Pediatric Disease Product; MIPLYFFA (Arimoclomol) khammond on DSKJM1Z7X2PROD with NOTICES 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health. Although this policy is being implemented immediately without prior comment, it remains subject to comment in accordance with FDA’s good guidance practices regulation (21 CFR 10.115(g)(3)(D)). FDA will consider all comments received and revise the guidance document as appropriate. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Endosseous Dental Implants and Endosseous Dental Implant Abutments—Performance Criteria for Safety and Performance Based Pathway. 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. AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease SUMMARY: 16:35 Oct 11, 2024 FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–1394. FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will SUPPLEMENTARY INFORMATION: Notice. VerDate Sep<11>2014 product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that MIPLYFFA (arimoclomol), approved on September 20, 2024, manufactured by Zevra Denmark AS, meets the criteria for a priority review voucher. Jkt 265001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 0910–0120 0910–0756 award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that MIPLYFFA (arimoclomol), manufactured by Zevra Denmark AS, meets the criteria for a priority review voucher. MIPLYFFA (arimoclomol) is indicated for the treatment of adults and pediatric patients 2 years of age and older with Niemann-Pick disease type C. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseases Conditions/RarePediatricDiseasePriority VoucherProgram/default.htm. For further information about MIPLYFFA (arimoclomol), go to the ‘‘Drugs@FDA’’ website at https:// www.accessdata.fda.gov/scripts/cder/ daf/. E:\FR\FM\15OCN1.SGM 15OCN1

Agencies

[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Pages 83019-83020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23716]



[[Page 83019]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-4409]


Endosseous Dental Implants and Endosseous Dental Implant 
Abutments--Performance Criteria for Safety and Performance Based 
Pathway; Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Endosseous Dental 
Implants and Endosseous Dental Implant Abutments--Performance Criteria 
for Safety and Performance Based Pathway.'' The device-specific 
guidance identified in this notice was developed in accordance with the 
finalized guidance entitled ``Safety and Performance Based Pathway.'' 
This guidance has been implemented without prior comment, but it 
remains subject to comment in accordance with the Agency's good 
guidance practices.

DATES: The announcement of the guidance is published in the Federal 
Register on October 15, 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-4409 for ``Endosseous Dental Implants and Endosseous Dental 
Implant Abutments--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 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 guidance document entitled 
``Endosseous Dental Implants and Endosseous Dental Implant Abutments--
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

    The Agency is announcing the availability of the final guidance 
document ``Endosseous Dental Implants and Endosseous Dental Implant 
Abutments--Performance Criteria for Safety and Performance Based 
Pathway.'' This device-specific guidance document provides 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 rooted in 
comparisons between new devices and predicate devices. However, the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) does not 
preclude FDA from using performance

[[Page 83020]]

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 an 
endosseous implant and endosseous implant abutment device 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.
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway.
---------------------------------------------------------------------------

    This guidance is being implemented without prior public comment 
because FDA has determined that prior public participation for this 
guidance 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 this guidance document presents a less burdensome 
policy that is consistent with public health. Although this policy is 
being implemented immediately without prior comment, it remains subject 
to comment in accordance with FDA's good guidance practices regulation 
(21 CFR 10.115(g)(3)(D)). FDA will consider all comments received and 
revise the guidance document as appropriate.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Endosseous Dental Implants and Endosseous 
Dental Implant Abutments--Performance Criteria for Safety and 
Performance Based Pathway. 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 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 or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Endosseous Dental Implants and 
Endosseous Dental Implant Abutments--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 GUI00021017 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 (44 U.S.C. 3501-3521). The collections of information in 
the following table have been approved by OMB:

------------------------------------------------------------------------
                                                            OMB Control
21 CFR part; guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
``Requests for Feedback and         Q-submissions and          0910-0756
 Meetings for Medical Device         Early Payor
 Submissions: The Q-Submission       Feedback Request
 Program''.                          Programs for
                                     Medical Devices.
------------------------------------------------------------------------


    Dated: October 4, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-23716 Filed 10-11-24; 8:45 am]
BILLING CODE 4164-01-P

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