[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80114-80116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-D-1647, FDA-2019-D-1652, and FDA-2019-D-1650]


Performance Criteria for Safety and Performance Based Pathway; 
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 three device-specific final guidance documents for 
the Safety and Performance Based Pathway--specifically, ``Spinal 
Plating Systems--Performance Criteria for Safety and Performance Based 
Pathway; Guidance for Industry and Food and Drug Administration 
Staff,'' ``Orthopedic Non-Spinal Metallic Bone Screws and Washers--
Performance Criteria for Safety and Performance Based Pathway; Guidance 
for Industry and Food and Drug Administration Staff,'' and ``Magnetic 
Resonance (MR) Receive-only Coil--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 final guidance 
entitled ``Safety and Performance Based Pathway.''

DATES: The announcement of the guidances is published in the Federal 
Register on December 11, 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:
    <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-2019-D-1647 for ``Spinal Plating Systems--Performance Criteria for 
Safety and Performance Based Pathway; Guidance for Industry and Food 
and Drug Administration Staff,'' Docket No. FDA-2019-D-1652 for 
``Orthopedic Non-Spinal Metallic Bone Screws and Washers--Performance 
Criteria for Safety and Performance Based Pathway; Guidance for 
Industry and Food and Drug Administration Staff,'' and Docket No. FDA-
2019-D-1650 for ``Magnetic Resonance (MR) Receive-only Coil--
Performance Criteria for Safety and Performance Based Pathway; Guidance 
for Industry and Food and Drug Administration Staff.'' 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

[[Page 80115]]

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.
    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 
``Spinal Plating Systems--Performance Criteria for Safety and 
Performance Based Pathway; Guidance for Industry and Food and Drug 
Administration Staff,'' ``Orthopedic Non-Spinal Metallic Bone Screws 
and Washers--Performance Criteria for Safety and Performance Based 
Pathway; Guidance for Industry and Food and Drug Administration 
Staff,'' or ``Magnetic Resonance (MR) Receive-only Coil--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.
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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 ``Spinal Plating 
Systems'' and ``Orthopedic Non-Spinal Metallic Bone Screws and 
Washers'' appeared in the Federal Register of September 20, 2019 (84 FR 
49528). A notice of availability of the draft guidance ``Magnetic 
Resonance Coil'' appeared in the Federal Register of December 9, 2019 
(84 FR 67272). FDA considered comments received on the ``Spinal Plating 
Systems'' guidance and revised the guidance as appropriate by 
clarifying the types of plates that are excluded from the scope of the 
guidance (i.e., occipital plates) and the lack of a specified minimum 
plate thickness. FDA considered comments received on the ``Orthopedic 
Non-Spinal Metallic Bone Screws and Washers'' guidance and revised the 
guidance as appropriate by expanding the scope of appropriate 
materials, clarifying the type of appropriate screw and washer design 
features, and clarifying the expectations for performance test methods 
and criteria. FDA considered comments received on the ``Magnetic 
Resonance Coil'' guidance and revised the guidance as appropriate by 
clarifying that the guidance is intended for receive-only magnetic 
resonance coils, expanding performance test methods with applicable 
FDA-recognized consensus standards, and clarifying the relation between 
performance testing and evaluations of interoperability.
    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 ``Spinal 
Plating Systems,'' ``Orthopedic Non-Spinal Metallic Bone Screws and 
Washers,'' and ``Magnetic Resonance Coil.'' 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 guidance 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 and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
Persons unable to download an electronic copy of either ``Spinal 
Plating Systems--Performance Criteria for Safety and Performance Based

[[Page 80116]]

Pathway; Guidance for Industry and Food and Drug Administration Staff'' 
(document number 19008), ``Orthopedic Non-Spinal Metallic Bone Screws 
and Washers--Performance Criteria for Safety and Performance Based 
Pathway; Guidance for Industry and Food and Drug Administration Staff'' 
(document number 19009), or ``Magnetic Resonance (MR) Receive-only 
Coil--Performance Criteria for Safety and Performance Based Pathway; 
Guidance for Industry and Food and Drug Administration Staff'' 
(document number 19011) may send an email request to <a href="/cdn-cgi/l/email-protection#f4b7b0a6bcd9b3819d90959a9791b4929095da9c9c87da939b82"><span class="__cf_email__" data-cfemail="723136203a5f35071b16131c1117321416135c1a1a015c151d04">[email protected]</span></a> 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

    While these guidances contain no 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 (PRA) (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 regulations and guidance have been 
approved by OMB as listed in the following table:

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                 21 CFR part or guidance                                 Topic                  OMB control No.
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807, subpart E..........................................  Premarket notification.............          0910-0120
``Requests for Feedback on Medical Device Submissions:    Q-submissions......................          0910-0756
 The Pre-Submission Program and Meetings with Food and
 Drug Administration Staff``.
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    Dated: December 7, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27248 Filed 12-10-20; 8:45 am]
BILLING CODE 4164-01-P


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