[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Notices]
[Pages 49655-49657]
[FR Doc No: 2020-17771]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-D-1649 and FDA-2019-D-1651]

Safety and Performance Based Pathway Device-Specific Guidances;
Guidances for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, Health and Human Services (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, ``Cutaneous
Electrode for Recording Purposes--Performance Criteria for Safety and
Performance Based Pathway; Guidance for Industry and Food and Drug
Administration Staff'' and ``Conventional Foley Catheters--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 finalized guidance entitled ``Safety and Performance Based
Pathway.''

DATES: The announcement of the guidance is published in the Federal
Register on August 14, 2020.

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-2019-D-1649 for ``Cutaneous Electrode for Recording Purposes--
Performance Criteria for Safety and Performance Based Pathway; Guidance
for Industry and Food and Drug Administration Staff'' and Docket No.
FDA-2019-D-1651 for ``Conventional Foley Catheters--Performance
Criteria for Safety and Performance Based Pathway; Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
will be placed in the dockets 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidances is 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 ``Cutaneous
Electrode for Recording Purposes--Performance Criteria for Safety and
Performance Based Pathway; Guidance for Industry and Food and Drug
Administration Staff'' or ``Conventional Foley Catheters--Performance
Criteria for Safety and Performance Based Pathway; Guidance for
Industry and Food and Drug Administration Staff '' to the Office of
Policy, Guidance and Policy Development, 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,<PHONE_NUMBER>.

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 appeared in the
Federal Register of September 20, 2019 (84 FR 49528). FDA did not
receive comments on the ``Cutaneous Electrode for Recording Purposes''
guidance; FDA considered comments received on the ``Conventional Foley
Catheters'' guidance and revised the guidance as appropriate, including
by clarifying, in the discussion of Biocompatibility Evaluation, when
material mediated pyrogenicity testing is recommended.
    These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidances represent
the current thinking of FDA on performance criteria for the ``Cutaneous
Electrode for Recording Purposes'' and ``Conventional Foley
Catheters.'' 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. Persons unable to download an
electronic copy of either ``Cutaneous Electrode for Recording
Purposes--Performance Criteria for Safety and Performance Based
Pathway; Guidance for Industry and Food and Drug Administration Staff
(document number 19014)'' or ``Conventional Foley Catheters--
Performance Criteria for Safety and Performance Based Pathway; Guidance
for Industry and Food and Drug Administration Staff (document number
19010)'' may send an email request to<EMAIL_ADDRESS>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

    These guidances contains no 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.
    However, these guidances refer to previously approved collections
of information. These 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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                                                            OMB control
       21 CFR part; guidance                Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
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    Dated: August 7, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17771 Filed 8-13-20; 8:45 am]
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