[Federal Register Volume 87, Number 71 (Wednesday, April 13, 2022)]
[Notices]
[Pages 21889-21890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07934]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0603 and FDA-2021-D-0604]


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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of two final device-specific guidance documents for 
the Safety and Performance Based Pathway--specifically, ``Denture Base 
Resins--Performance Criteria for Safety and Performance Based Pathway; 
Guidance for Industry and Food and Drug Administration Staff'' and 
``Facet Screw Systems--Performance Criteria for Safety and Performance 
Based Pathway; Guidance for Industry and Food and Drug Administration 
Staff.'' The device-specific guidances identified in this notice were 
developed in accordance with the final guidance entitled ``Safety and 
Performance Based Pathway.''

DATES: The announcement of the guidance is published in the Federal 
Register on April 13, 2022.

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-2021-D-0603 for ``Denture Base Resins--Performance Criteria for 
Safety and Performance Based Pathway; Guidance for Industry and Food 
and Drug Administration Staff'' or Docket No. FDA-2021-D-0604 for 
``Facet Screw Systems--Performance Criteria for Safety and Performance 
Based Pathway; Guidance for Industry and Food and Drug Administration 
Staff.'' 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 
``Denture Base Resins--Performance Criteria for Safety and Performance 
Based Pathway; Guidance for Industry and Food and Drug Administration 
Staff'' or ``Facet Screw Systems--Performance Criteria for Safety and 
Performance Based Pathway; Guidance for Industry and Food and Drug 
Administration Staff'' to the Office of Policy, Center for Devices

[[Page 21890]]

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

    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 rooted in 
comparisons between new devices and predicate devices. However, the 
Federal Food, Drug, and Cosmetic 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 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 above-listed guidances, 
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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    A notice of availability of the draft guidances ``Denture Base 
Resins'' and ``Facet Screw Systems'' appeared in the Federal Register 
of August 30, 2021 (86 FR 48430). FDA considered comments received on 
the ``Denture Base Resins'' and revised the guidance as appropriate by 
clarifying what information should be included in premarket submissions 
for denture resins that are additively manufactured. There were no 
comments received for the ``Facet Screw Systems'' guidance.
    These guidance documents are being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The guidance 
documents represent the current thinking of FDA on performance criteria 
for ``Denture Base Resins'' and ``Facet Screw Systems.'' 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 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 either ``Denture Base Resins--
Performance Criteria for Safety and Performance Based Pathway; Guidance 
for Industry and Food and Drug Administration Staff (document number 
20001)'' or ``Facet Screw Systems--Performance Criteria for Safety and 
Performance Based Pathway; Guidance for Industry and Food and Drug 
Administration Staff (document number 21001)'' may send an email 
request to [email protected] 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 guidance documents contain no new collection of 
information, they do refer to previously approved FDA collections of 
information. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3521) is not required for these guidance documents. The previously 
approved collections of information are subject to review by OMB under 
the PRA. The collections of information in the following FDA 
regulations and guidance have been approved by OMB as listed in the 
following table:

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           21 CFR part or guidance                       Topic                       OMB control No.
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807, subpart E...............................  Premarket notification..                                0910-0120
``Requests for Feedback and Meetings for       Q-submissions; Pre-                                     0910-0756
 Medical Device Submissions: The Q-Submission   submissions.
 Program''.
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    Dated: April 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07934 Filed 4-12-22; 8:45 am]
BILLING CODE 4164-01-P


