Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 16517-16519 [2019-07936]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Notices
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single hard copy of the draft guidance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 ‘‘Technical
Considerations for Non-Clinical
Assessment of Medical Devices
containing Nitinol’’ 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 selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Matthew Di Prima, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 2214, Silver Spring,
MD 20993–0002, 301–796–2507.
SUPPLEMENTARY INFORMATION:
I. Background
The use of nitinol in medical devices
began over 3 decades ago in product
areas such as orthodontic archwires,
cardiovascular guidewires, and surgical
instruments. Its use has increased over
the past 2 decades into different device
areas such as orthopedic fracture
fixation, cardiovascular stents, and
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This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Technical Considerations for NonClinical Assessment of Medical Devices
containing Nitinol’’. 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
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
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of the draft guidance may do so by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/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Technical Considerations for NonClinical Assessment of Medical Devices
containing Nitinol’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 17013 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. 3501–3520). The
collections of information in the
following FDA regulations and guidance
have been approved by OMB as listed in
the following table:
OMB control
No.
21 CFR part or guidance
Topic
807, subpart E ............................................................................
814, subparts A through E ..........................................................
814, subpart H ............................................................................
812 ..............................................................................................
‘‘De Novo Classification Process (Evaluation of Automatic
Class III Designation)’’.
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff‘‘.
801 ..............................................................................................
Premarket notification ................................................................
Premarket approval ....................................................................
Humanitarian Device Exemption ...............................................
Investigational Device Exemption ..............................................
De Novo classification process ..................................................
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
Q-submissions ...........................................................................
0910–0756
Medical Device Labeling Regulations ........................................
0910–0485
Dated: April 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07931 Filed 4–18–19; 8:45 am]
BILLING CODE 4164–01–P
khammond on DSKBBV9HB2PROD with NOTICES
transcatheter heart valves. With an
increasing trend to treat patients using
minimally invasive procedures, nitinol
has become a popular choice of material
due to its ability to return to its original
shape after being deformed or after heat
is applied. Given the complex
thermomechanical behavior of nitinol,
there are unique considerations when
assessing the safety and performance of
nitinol-containing devices.
The Agency has developed this draft
guidance to provide FDA’s current
thinking on technical considerations
specific to devices using nitinol. These
recommendations are intended to be
general and not product-specific, and
apply to medical devices that have at
least one patient contacting component
comprised of nitinol.
16517
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1470]
Technical Performance Assessment of
Quantitative Imaging in Premarket
Device Submissions; Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Sep<11>2014
16:23 Apr 18, 2019
Jkt 247001
PO 00000
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Technical
Performance Assessment of Quantitative
Imaging in Premarket Device
Submissions.’’ This draft guidance
document provides recommendations
on the information that should be
included in premarket submissions for
devices that include quantitative
imaging functions. This draft guidance
is not final nor is it in effect at this time.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by June 18, 2019 to ensure that the
DATES:
Notice of availability.
Frm 00063
Fmt 4703
Sfmt 4703
E:\FR\FM\19APN1.SGM
19APN1
16518
Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Notices
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:
khammond on DSKBBV9HB2PROD 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–1470 for ‘‘Technical
Performance Assessment of Quantitative
Imaging in Premarket Device
Submissions.’’ 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
VerDate Sep<11>2014
16:23 Apr 18, 2019
Jkt 247001
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 ‘‘Technical
Performance Assessment of Quantitative
Imaging in Premarket Device
Submissions’’ 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: Dina
Jerebitski, Center for Devices and
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring,
MD 20993–0002, 301–796–2411.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document
provides recommendations on the
information that should be included in
premarket submissions for devices that
include quantitative imaging functions.
Medical imaging is used routinely in
hospitals and clinics to assist with the
diagnosis and management of patients
with a variety of diseases and
conditions, by providing visual
representations of the internal structures
of the body. Most medical images are
acquired with the intention of
qualitative interpretation by a trained
physician to identify the presence or
absence of a structure or feature.
Quantitative imaging extracts additional
information from medical images in the
form of numerical values.
This draft guidance document is
applicable to all devices that generate
quantitative imaging values across a
wide range of imaging modalities,
intended uses, levels of automation, and
complexity of algorithm. For the
purpose of this document, FDA
considers quantitative imaging values to
be objective characteristics measured on
a ratio or interval scale; that is,
measured parameters derived from
medical images that have physical
meaning.
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 ‘‘Technical Performance Assessment
of Quantitative Imaging in Premarket
Device Submissions.’’ 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
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
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/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov. Persons
E:\FR\FM\19APN1.SGM
19APN1
Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Notices
unable to download an electronic copy
of ‘‘Technical Performance Assessment
of Quantitative Imaging in Premarket
Device Submissions’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
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. 3501–3520). The
collections of information in the
following FDA regulations and
guidances have been approved by OMB
as listed in the following table:
OMB Control
No.
21 CFR Part; guidance; or FDA form
Topic
807, subpart E ................................................................................................
814, subparts A through E .............................................................................
814, subpart H ................................................................................................
812 ..................................................................................................................
‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’.
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’.
800, 801, and 809 ..........................................................................................
Premarket notification ............................................
Premarket approval ................................................
Humanitarian Device Exemption ............................
Investigational Device Exemption ..........................
De Novo classification process ..............................
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
Q-submissions ........................................................
0910–0756
Medical Device Labeling Regulations ....................
0910–0485
Dated: April 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07936 Filed 4–18–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0065]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration of
Food Facilities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of the Agency’s
regulations that require registration for
domestic and foreign facilities that
manufacture, process, pack, or hold
food for human or animal consumption
in the United States.
DATES: Submit either electronic or
written comments on the collection of
information by June 18, 2019.
SUMMARY:
khammond on DSKBBV9HB2PROD with NOTICES
number 18017 to identify the guidance
you are requesting.
16519
VerDate Sep<11>2014
16:23 Apr 18, 2019
Jkt 247001
ADDRESSES:
Written/Paper Submissions
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’’).
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–
2013–N–0065 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Registration of Food Facilities Under the
Public Health Security and Bioterrorism
Preparedness and Response Act of
2002.’’ Received comments, those filed
in a timely manner (see ADDRESSES),
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
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 18, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 18, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
E:\FR\FM\19APN1.SGM
19APN1
]]>Agencies
[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Notices]
[Pages 16517-16519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07936]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-1470]
Technical Performance Assessment of Quantitative Imaging in
Premarket Device Submissions; 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 ``Technical Performance
Assessment of Quantitative Imaging in Premarket Device Submissions.''
This draft guidance document provides recommendations on the
information that should be included in premarket submissions for
devices that include quantitative imaging functions. This draft
guidance is not final nor is it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by June 18, 2019 to ensure that the
[[Page 16518]]
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-1470 for ``Technical Performance Assessment of Quantitative
Imaging in Premarket Device Submissions.'' 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
``Technical Performance Assessment of Quantitative Imaging in Premarket
Device Submissions'' 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: Dina Jerebitski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-
796-2411.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document provides recommendations on the
information that should be included in premarket submissions for
devices that include quantitative imaging functions. Medical imaging is
used routinely in hospitals and clinics to assist with the diagnosis
and management of patients with a variety of diseases and conditions,
by providing visual representations of the internal structures of the
body. Most medical images are acquired with the intention of
qualitative interpretation by a trained physician to identify the
presence or absence of a structure or feature. Quantitative imaging
extracts additional information from medical images in the form of
numerical values.
This draft guidance document is applicable to all devices that
generate quantitative imaging values across a wide range of imaging
modalities, intended uses, levels of automation, and complexity of
algorithm. For the purpose of this document, FDA considers quantitative
imaging values to be objective characteristics measured on a ratio or
interval scale; that is, measured parameters derived from medical
images that have physical meaning.
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 ``Technical
Performance Assessment of Quantitative Imaging in Premarket Device
Submissions.'' 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 it satisfies the requirements of the applicable statutes and
regulations. This guidance is not subject to Executive Order 12866.
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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons
[[Page 16519]]
unable to download an electronic copy of ``Technical Performance
Assessment of Quantitative Imaging in Premarket Device Submissions''
may send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number 18017
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. 3501-3520). The collections of information in
the following FDA regulations and guidances have been approved by OMB
as listed in the following table:
------------------------------------------------------------------------
21 CFR Part; guidance; or FDA OMB Control
form Topic No.
------------------------------------------------------------------------
807, subpart E.................. Premarket notification 0910-0120
814, subparts A through E....... Premarket approval.... 0910-0231
814, subpart H.................. Humanitarian Device 0910-0332
Exemption.
812............................. Investigational Device 0910-0078
Exemption.
``De Novo Classification Process De Novo classification 0910-0844
(Evaluation of Automatic Class process.
III Designation)''.
``Requests for Feedback on Q-submissions......... 0910-0756
Medical Device Submissions: The
Pre-Submission Program and
Meetings with Food and Drug
Administration Staff''.
800, 801, and 809............... Medical Device 0910-0485
Labeling Regulations.
------------------------------------------------------------------------
Dated: April 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07936 Filed 4-18-19; 8:45 am]
BILLING CODE 4164-01-P
