Notice2022-07684
Safety and Performance Based Pathway Device-Specific Guidances; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
April 11, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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."
Full Text
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<title>Federal Register, Volume 87 Issue 69 (Monday, April 11, 2022)</title>
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[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21124-21126]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
[[Page 21125]]
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway</a>.
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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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. These guidance documents are
also available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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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