[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21124-21126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0552]


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 two final device-specific guidance documents for 
the Safety and Performance Based Pathway--specifically, ``Surgical 
Sutures--Performance Criteria for Safety and Performance Based 
Pathway'' and ``Orthopedic Fracture Fixation Plates--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 April 11, 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:
    <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-2022-D-0552 for ``Surgical Sutures--Performance Criteria for Safety 
and Performance Based Pathway'' or ``Orthopedic Fracture Fixation 
Plates--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.

[[Page 21125]]

    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 
``Surgical Sutures--Performance Criteria for Safety and Performance 
Based Pathway; Guidance for Industry and Food and Drug Administration 
Staff'' or the guidance document entitled ``Orthopedic Fracture 
Fixation Plates--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 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 FDA is announcing the availability of two final device-specific 
guidance documents for the Safety and Performance Based Pathway--
specifically, ``Surgical Sutures--Performance Criteria for Safety and 
Performance Based Pathway'' and ``Orthopedic Fracture Fixation Plates--
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 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 a 
surgical suture or orthopedic fracture fixation plate 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.
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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 ``Surgical Sutures--
Performance Criteria for Safety and Performance Based Pathway'' and 
``Orthopedic Fracture Fixation Plates--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 ``Surgical Sutures--Performance Criteria 
for Safety and Performance Based Pathway'' or ``Orthopedic Fracture 
Fixation Plates--Performance Criteria for Safety and Performance Based 
Pathway'' may send an email request to <a href="/cdn-cgi/l/email-protection#c083849288ed87b5a9a4a1aea3a580a6a4a1eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="dd9e998f95f09aa8b4b9bcb3beb89dbbb9bcf3b5b5aef3bab2ab">[email protected]</span></a> to 
receive an electronic copy of the document. Please use the document 
number 20002 for ``Surgical Sutures--Performance Criteria for Safety 
and Performance Based Pathway'' or document number 19044 for 
``Orthopedic Fracture Fixation Plates--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. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not 
required for these guidances. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulation and guidance have been 
approved by OMB as listed in the following table:

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      21 CFR part; guidance               Topic          OMB control No.
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807, subpart E...................  Premarket                   0910-0120
                                    notification.

[[Page 21126]]

 
``Requests for Feedback and        Q-submissions; pre-         0910-0756
 Meetings for Medical Device        submissions.
 Submissions: The Q-Submission
 Program''.
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    Dated: April 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07684 Filed 4-8-22; 8:45 am]
BILLING CODE 4164-01-P


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