Document ID: FDA-2019-D-1647-0001
Agency: fda
Document Type: Notice
Title: Safety and Performance Based Pathway Device-Specific Guidance;
Draft Guidances for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2019-09-20T04:00Z

[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Notices]
[Pages 49528-49530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20370]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-D-1647, FDA-2019-D-1649, FDA-2019-D-1651, and 
FDA-2019-D-1652]

Safety and Performance Based Pathway Device-Specific Guidance; 
Draft Guidances 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the availability of several device-specific draft guidance documents 
for the Safety and Performance Based Pathway--specifically, ``Spinal 
Plating Systems--Performance Criteria for Safety and Performance Based 
Pathway; Draft Guidance for Industry and Food and Drug Administration 
Staff''; ``Cutaneous Electrode for Recording Purposes--Performance 
Criteria for Safety and Performance Based Pathway; Draft Guidance for 
Industry and Food and Drug Administration Staff''; ``Conventional Foley 
Catheters--Performance Criteria for Safety and Performance Based 
Pathway; Draft Guidance for Industry and Food and Drug Administration 
Staff''; and ``Orthopedic Non-Spinal Metallic Bone Screws and Washers--
Performance Criteria for Safety and Performance Based Pathway; Draft 
Guidance for Industry and Food and Drug Administration Staff.'' The 
device-specific draft guidances identified in this notice were 
developed in accordance with the finalized guidance entitled ``Safety 
and Performance Based Pathway.'' These draft guidances are not final 
nor are they in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidances by December 19, 2019 to ensure that the Agency considers your 
comment on these draft guidance documents before it begins work on the 
final version of the guidance documents.

ADDRESSES: You may submit comments on any guidance 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 49529]]

     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 Docket No. FDA-
2019-D-1647 for ``Spinal Plating Systems--Performance Criteria for 
Safety and Performance Based Pathway; Draft Guidance for Industry and 
Food and Drug Administration Staff''; Docket No. FDA-2019-D-1649 for 
``Cutaneous Electrode for Recording Purposes--Performance Criteria for 
Safety and Performance Based Pathway; Draft Guidance for Industry and 
Food and Drug Administration Staff''; Docket No. FDA-2019-D-1651 for 
``Conventional Foley Catheters--Performance Criteria for Safety and 
Performance Based Pathway; Draft Guidance for Industry and Food and 
Drug Administration Staff''; and Docket No. FDA-2019-D-1652 for 
``Orthopedic Non-Spinal Metallic Bone Screws and Washers--Performance 
Criteria for Safety and Performance Based Pathway; Draft 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidances 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 draft guidances entitled ``Spinal Plating 
Systems--Performance Criteria for Safety and Performance Based Pathway; 
Draft Guidance for Industry and Food and Drug Administration Staff,'' 
``Cutaneous Electrode for Recording Purposes--Performance Criteria for 
Safety and Performance Based Pathway; Draft Guidance for Industry and 
Food and Drug Administration Staff,'' ``Conventional Foley Catheters--
Performance Criteria for Safety and Performance Based Pathway; Draft 
Guidance for Industry and Food and Drug Administration Staff,'' or 
``Orthopedic Non-Spinal Metallic Bone Screws and Washers--Performance 
Criteria for Safety and Performance Based Pathway; Draft 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 draft guidances provide performance criteria 
for premarket notification (510k) 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, when finalized, 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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II. Significance of Guidance

    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These draft guidances, 
when finalized, will represent the current thinking of FDA on 
performance criteria for the ``Safety and Performance Based Pathway for 
Spinal Plating Systems,'' ``Cutaneous Electrode for Recording 
Purposes,'' ``Conventional Foley Catheters,'' and ``Orthopedic Non-

[[Page 49530]]

Spinal Metallic Bone Screws and Washers.'' 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. These guidances are not subject to 
Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. These draft 
guidances are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of either ``Spinal Plating 
Systems--Performance Criteria for Safety and Performance Based Pathway; 
Draft Guidance for Industry and Food and Drug Administration Staff 
(document number 19008),'' ``Cutaneous Electrode for Recording 
Purposes--Performance Criteria for Safety and Performance Based 
Pathway; Draft Guidance for Industry and Food and Drug Administration 
Staff (document number 19014),'' ``Conventional Foley Catheters--
Performance Criteria for Safety and Performance Based Pathway; Draft 
Guidance for Industry and Food and Drug Administration Staff (document 
number 19010),'' or ``Orthopedic Non-Spinal Metallic Bone Screws and 
Washers--Performance Criteria for Safety and Performance Based Pathway; 
Draft Guidance for Industry and Food and Drug Administration Staff 
(document number 19009)'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the documents. 
Please use the document number and complete title to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    These draft guidance documents refer to previously approved 
collections of information. These collections of information are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information have been approved by OMB as listed in the 
following table:

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                                                           OMB  control
      21 CFR part or 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 Q-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
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    Dated: September 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20370 Filed 9-19-19; 8:45 am]
 BILLING CODE 4164-01-P