[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Notices]
[Pages 49655-49657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17771]


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

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.

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

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.

[[Page 49656]]

     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, 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 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, 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.
---------------------------------------------------------------------------

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

    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

[[Page 49657]]

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 CDRH-Guidance@fda.hhs.gov 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:

 
------------------------------------------------------------------------
                                                            OMB control
       21 CFR part; guidance                Topic               No.
------------------------------------------------------------------------
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''.
------------------------------------------------------------------------


    Dated: August 7, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17771 Filed 8-13-20; 8:45 am]
BILLING CODE 4164-01-P


