[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the availability of several device-specific draft guidance documents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Pathway; Draft Guidance for Industry and Food and Drug Administration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Criteria for Safety and Performance Based Pathway; Draft Guidance for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Pathway; Draft Guidance for Industry and Food and Drug Administration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Performance Criteria for Safety and Performance Based Pathway; Draft
Guidance for Industry and Food and Drug Administration Staff.''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comment on these draft guidance documents before it begins work on the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 [email protected] 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