Magnetic Resonance Coil-Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 67272-67274 [2019-26470]
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Federal Register / Vol. 84, No. 236 / Monday, December 9, 2019 / Notices
Caregivers Act of 2017 requires that the
Secretary (of HHS) establish a process
for public input to inform the
development and updating of the
Strategy, including a process to submit
recommendations to the FCAC and
provide public input on the same.
Family caregiving crosses racial,
ethnic, socioeconomic, and cultural
boundaries. It affects those in rural and
urban settings and can span generations
in a single household. A robust national
strategy to support America’s caregivers
must take into consideration not only
caregivers of older adults, but also those
facing long-term care and respite care
needs for those of any age resulting from
any serious illnesses, conditions or
disabilities. The strategy should also
address the needs and considerations of
caregivers of persons with Alzheimer’s
disease or a related dementia and
people with intellectual or
developmental disabilities.
khammond on DSKJM1Z7X2PROD with NOTICES
Public Input
Through this RFI, ACL is seeking
input from individuals and
organizations that capture the breadth of
the family caregiving experience.
Specifically, we would like to learn
from you based on your experience
about challenges faced by family
caregivers. In this regard, please keep in
mind the following:
• All submissions will be considered
and reviewed by the Family Caregiving
Advisory Council.
• The Council seeks
recommendations and actions to
optimize solutions for family caregivers
for inclusion in the National Strategy.
(We may not be able to include all
recommendations.)
• If you have multiple needs,
concerns and/or recommendations, you
may make multiple submissions.
• A pressing family caregiving need
or concern is something you feel
requires consideration for inclusion in
the Strategy.
• A recommendation proposes a
solution to the identified need/concern.
• A challenge is a categorization of
the recommendation that may be, but
not limited to: General, access, finance,
health, and other. To the extent
possible, please categorize your
recommendation as follows: Greater
adoption of person/family-centered
care; assessment; service planning and/
or delivery; care transitions/
coordination; information, education,
referral, training and advance planning;
respite options; financial security;
workplace issues; and/or other.
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Submission Questions
1. A pressing family caregiving need/
concern I would like to see addressed is:
2. I would like to offer this specific
recommendation to address my need/
concern: The recommendation
addresses needed actions that pertain to:
Please Note: This RFI is being issued for
information and planning purposes only. It
should not be construed as a solicitation or
an obligation on the part of the federal
government or the Administration for
Community Living (ACL). ACL does not
intend to issue any grant or contract awards
based on responses to this invitation, or to
otherwise pay for the preparation of any
information submitted or for the
government’s use of such information. ACL
is not authorized to receive personally
identifiable information (PII) through this RFI
other than the contact information of the
person submitting the information. Please do
not include any PII in your submission. For
example,F do not include names, addresses,
phone or Social Security numbers of any
individuals. We will immediately delete and
not review responses that contain PII.
How the Information Will Be Used
ACL and the FCAC are planning for
the Council’s future activities, including
the preparation of an Initial Report and
the Family Caregiving Strategy.
Additionally, ACL is developing a series
of public listening sessions starting in
calendar year 2020 as a way to engage
with members of the public, families
and family caregivers, stakeholders and
other individuals and entities with an
interest in understanding and
supporting the multi-faceted needs of
family caregivers across the age and
disability spectrum. The information
gathered through this RFI will be used
to inform each of these activities and
seek feedback from the public where/
when appropriate.
Background
The RAISE Family Caregivers Act was
signed into law on January 22, 2018.
The RAISE Act requires the Secretary of
HHS to promote improvement of the
Federal, State, and community systems
that support family caregivers. The two
primary objectives of the RAISE Act are
to:
1. Establish a national Family
Caregiving Strategy with
recommendations for ensuring personand family-centered care, assessment
and service planning, information on
accessing hospice and palliative care,
respite options, financial security and
workplace issues, and delivering
services in an effective and efficient
manner; and
2. Establish a Family Caregiving
Advisory Council of Federal and nonFederal representatives to provide
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recommendations and identify best
practices to recognize and support
family caregivers.
Public input is a key expectation of
the RAISE Act. This RFI is the first
opportunity for ACL to ensure that the
activities and products of the FCAC are
inclusive of and responsive to, the
needs and expectations of a range of
stakeholders with an interest in
supporting family caregivers.
How To Submit a Response to This RFI
Comments should be submitted
online at: https://acl.gov/form/publicinput-raise.
Submission Due Date
To be assured consideration, all
responses to this RFI must be received
by 5:00 p.m., EST on February 7, 2020.
For Further Information
If you have questions about this
request, please email them to
RAISEAct@acl.hhs.gov. This is a
resource mailbox established to receive
public input for the RAISE Act, and
should not be used to request
information beyond the scope of this
public input opportunity.
Dated: December 2, 2019.
Lance Robertson,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2019–26438 Filed 12–6–19; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1650]
Magnetic Resonance Coil—
Performance Criteria for Safety and
Performance Based Pathway; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Magnetic Resonance
(MR) Coil—Performance Criteria for
Safety and Performance Based Pathway;
Draft Guidance for Industry and Food
and Drug Administration Staff.’’ The
device-specific guidance identified in
this notice was developed in accordance
with the final guidance entitled ‘‘Safety
and Performance Based Pathway.’’ This
draft guidance is not final nor is it in
effect at this time.
SUMMARY:
E:\FR\FM\09DEN1.SGM
09DEN1
Federal Register / Vol. 84, No. 236 / Monday, December 9, 2019 / Notices
Submit either electronic or
written comments on the draft guidance
by February 7, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
khammond on DSKJM1Z7X2PROD with NOTICES
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–1650 for ‘‘Magnetic Resonance
(MR) Coil—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 docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
VerDate Sep<11>2014
17:22 Dec 06, 2019
Jkt 250001
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/201523389.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 guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Magnetic Resonance
(MR) Coil—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,
PO 00000
Frm 00020
Fmt 4703
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67273
MD 20993–0002. Send one selfaddressed 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
This draft device-specific guidance
document provides 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 guidance, when
finalized, rather than using direct
predicate comparison testing for some of
the performance characteristics.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on performance criteria for the Safety
and Performance Based Pathway for
magnetic resonance coils. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
1 Available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/
safety-and-performance-based-pathway.
E:\FR\FM\09DEN1.SGM
09DEN1
67274
Federal Register / Vol. 84, No. 236 / Monday, December 9, 2019 / Notices
it satisfies the requirements of the
applicable statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
IV. Paperwork Reduction Act of 1995
This draft guidance refers 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. 3501–3521). The
collections of information in the
following FDA guidance have been
approved by OMB as listed in the
following table:
21 CFR part; guidance; or FDA form
Topic
807, subpart E ..............................................................................................................
‘‘Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff’’.
Premarket Notification ..............................
Q-Submissions ..........................................
Dated: December 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26470 Filed 12–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–4433]
Development of Locally Applied
Corticosteroid Products for the ShortTerm Treatment of Symptoms
Associated With Internal or External
Hemorrhoids; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Development of Locally Applied
Corticosteroid Products for the ShortTerm Treatment of Symptoms
Associated with Internal or External
Hemorrhoids.’’ This draft guidance will
serve as a focus for continued
discussions among the Division of
Gastroenterology and Inborn Error
Products, pharmaceutical sponsors, the
academic community, and the public.
DATES: Submit either electronic or
written comments on the draft guidance
by February 7, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Magnetic Resonance (MR) Coil—
Performance Criteria for Safety and
Performance Based Pathway; Draft
Guidance for Industry and Food and
Drug Administration Staff (document
number 19011)’’ 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.
VerDate Sep<11>2014
17:22 Dec 06, 2019
Jkt 250001
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
OMB control
No.
0910–0120
0910–0756
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–4433 for ‘‘Development of
Locally Applied Corticosteroid Products
for the Short-Term Treatment of
Symptoms Associated with Internal or
External Hemorrhoids.’’ 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
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
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[Federal Register Volume 84, Number 236 (Monday, December 9, 2019)]
[Notices]
[Pages 67272-67274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26470]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-1650]
Magnetic Resonance Coil--Performance Criteria for Safety and
Performance Based Pathway; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Magnetic Resonance
(MR) Coil--Performance Criteria for Safety and Performance Based
Pathway; Draft Guidance for Industry and Food and Drug Administration
Staff.'' The device-specific guidance identified in this notice was
developed in accordance with the final guidance entitled ``Safety and
Performance Based Pathway.'' This draft guidance is not final nor is it
in effect at this time.
[[Page 67273]]
DATES: Submit either electronic or written comments on the draft
guidance by February 7, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
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.
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-1650 for ``Magnetic Resonance (MR) Coil--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 docket 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 guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Magnetic Resonance (MR) Coil--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
This draft device-specific guidance document provides 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 guidance, when
finalized, 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.
---------------------------------------------------------------------------
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on performance
criteria for the Safety and Performance Based Pathway for magnetic
resonance coils. It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if
[[Page 67274]]
it satisfies the requirements of the applicable statutes and
regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft 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. This guidance document is also
available at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Magnetic Resonance (MR) Coil--Performance Criteria
for Safety and Performance Based Pathway; Draft Guidance for Industry
and Food and Drug Administration Staff (document number 19011)'' may
send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number and
complete title to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers 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. 3501-3521). The collections of information in
the following FDA guidance have been approved by OMB as listed in the
following table:
------------------------------------------------------------------------
OMB control
21 CFR part; guidance; or FDA form Topic No.
------------------------------------------------------------------------
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''.
------------------------------------------------------------------------
Dated: December 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26470 Filed 12-6-19; 8:45 am]
BILLING CODE 4164-01-P
