Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 72971-72973 [2021-27825]
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Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices
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Submissions’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1500056 and complete title to
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does 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 this guidance.
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 guidances have been
approved by OMB as listed in the
following table:
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 and Meetings for Medical Device Submissions: The QSubmission Program’’.
Premarket notification ...............................
Premarket approval ..................................
Humanitarian Device Exemption ..............
Investigational Device Exemption .............
De Novo classification process ................
Q-submissions; pre-submissions ..............
Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
Submit either electronic or
written comments on the draft guidance
by February 22, 2022 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draft guidance before it begins work on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:
[FR Doc. 2021–27812 Filed 12–22–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0996]
Technical Considerations for Medical
Devices With Physiologic Closed-Loop
Control Technology; 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 ‘‘Technical
Considerations for Medical Devices with
Physiologic Closed-Loop Control
Technology.’’ Physiologic Closed-Loop
Control (PCLC) devices are intended for
automatic control of a physiologic
variable(s) through delivery of energy or
substance using feedback from
physiologic sensors. PCLC devices may
play an important role in reducing
cognitive overload, minimizing human
error, and enhancing medical care
during emergency response and medical
surge situations. This draft guidance
provides technical considerations for
PCLC technology in order to promote
development and availability of safe and
effective PCLC medical devices. This
draft guidance is not final nor is it in
effect at this time.
SUMMARY:
jspears on DSK121TN23PROD with NOTICES1
identify the guidance you are
requesting.
VerDate Sep<11>2014
20:50 Dec 22, 2021
Jkt 256001
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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
72971
OMB Control
No.
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
0910–0756
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–
2021–D–0996 for ‘‘Technical
Considerations for Medical Devices with
Physiologic Closed-Loop Control
Technology.’’ 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, 240–402–7500.
• 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
E:\FR\FM\23DEN1.SGM
23DEN1
72972
Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices
jspears on DSK121TN23PROD with NOTICES1
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-201509-18/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
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 Medical Devices with
Physiologic Closed-Loop Control
Technology’’ to the Office of Policy,
Center for Devices and Radiological
Health (CDRH), 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:
Christopher Scully, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 1129, Silver Spring,
MD 20993–0002, 301–796–2928.
SUPPLEMENTARY INFORMATION:
I. Background
PCLC technology can enable
automation in a variety of medical
device types including infusion
systems, ventilators, extracorporeal
systems, and stimulation systems.
Automated adjustments of a physiologic
variable(s) through the delivery of
energy or substance (i.e., therapy), such
as automated fluid resuscitation,
ventilation/oxygenation, and anesthesia
delivery, are emerging applications for
the critical and emergency care
environments. PCLC devices may
benefit the patient by facilitating safe
and effective, consistent, and timely
delivery of appropriate therapy with
improved and distraction-free
performance. However, introducing
automation and reducing clinician
involvement can incur new types of
hazards which may render the medical
device unsafe if not properly designed
or evaluated. This guidance provides
technical considerations for PCLC
technology during device development
to support the safe and effective design
and evaluation of PCLC medical
devices.
CDRH held a public workshop
entitled ‘‘Physiological Closed-Loop
Controlled Devices’’ on October 13 and
14, 2015,1 with the aim of fostering an
open discussion on design and
evaluation considerations associated
with PCLC devices used in critical care
environments. This workshop provided
a forum for medical device
manufacturers, clinical users, and
academia to discuss technical
considerations for automated medical
devices with PCLC technology. The
feedback and recommendations
provided at the meeting were
incorporated in this draft 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
Medical Devices with Physiologic
Closed-Loop Control Technology. 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.
II. 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
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Technical
Considerations for Medical Devices with
Physiologic Closed-Loop Control
Technology’’ may send an email request
to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the
document. Please use the document
number 1500085 and complete title to
identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does 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 this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations, guidance, and forms 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
1 See https://wayback.archive-it.org/7993/
20170112084803/http:/www.fda.gov/
VerDate Sep<11>2014
20:50 Dec 22, 2021
Jkt 256001
MedicalDevices/NewsEvents/
WorkshopsConferences/ucm457581.htm.
PO 00000
Frm 00056
Fmt 4703
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Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices
Topic
803 ..............................................................................................
Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor
reporting.
Current Good Manufacturing Practice (CGMP); Quality System
(QS) Regulation.
Good Laboratory Practice (GLP) Regulations for Nonclinical
Laboratory Studies.
58 ................................................................................................
Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27825 Filed 12–22–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1118]
Transition Plan for Medical Devices
That Fall Within Enforcement Policies
Issued During the Coronavirus Disease
2019 Public Health Emergency; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability;
Agency Information Collection
Activities; Proposed Collection;
Comment Request
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of the draft
guidance entitled ‘‘Transition Plan for
Medical Devices That Fall Within
Enforcement Policies Issued During the
Coronavirus Disease 2019 (COVID–19)
Public Health Emergency.’’ FDA
recognizes that it will take time for
device manufacturers, healthcare
facilities, healthcare providers, patients,
consumers, and FDA to adjust from
policies adopted and operations
implemented during the declared public
health emergency (PHE) to normal
operations. To provide a clear policy for
all stakeholders and FDA staff, the
Agency is issuing this guidance to
describe FDA’s general
recommendations for a phased
transition process with respect to
devices that fall within enforcement
policies issued during the COVID–19
PHE, including recommendations
regarding submitting a marketing
submission, as applicable, and taking
other actions with respect to these
devices. FDA is concurrently issuing a
companion guidance to describe FDA’s
recommendations for this transition
SUMMARY:
jspears on DSK121TN23PROD with NOTICES1
OMB Control
No.
21 CFR part; guidance; or FDA form
820 ..............................................................................................
VerDate Sep<11>2014
20:50 Dec 22, 2021
Jkt 256001
process with respect to devices issued
Emergency Use Authorizations (EUAs)
during the COVID–19 PHE. 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 March 23, 2022 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
Submit either electronic or written
comments on the collection of
information by February 22, 2022.
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.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
72973
0910–0437
0910–0073
0910–0119
• 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–
2021–D–1118 for ‘‘Transition Plan for
Medical Devices That Fall Within
Enforcement Policies Issued During the
Coronavirus Disease 2019 (COVID–19)
Public Health Emergency.’’ 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, 240–402–7500.
• 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-201509-18/pdf/2015-23389.pdf.
E:\FR\FM\23DEN1.SGM
23DEN1
]]>Agencies
[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72971-72973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27825]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0996]
Technical Considerations for Medical Devices With Physiologic
Closed-Loop Control Technology; 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
Considerations for Medical Devices with Physiologic Closed-Loop Control
Technology.'' Physiologic Closed-Loop Control (PCLC) devices are
intended for automatic control of a physiologic variable(s) through
delivery of energy or substance using feedback from physiologic
sensors. PCLC devices may play an important role in reducing cognitive
overload, minimizing human error, and enhancing medical care during
emergency response and medical surge situations. This draft guidance
provides technical considerations for PCLC technology in order to
promote development and availability of safe and effective PCLC medical
devices. 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 February 22, 2022 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-2021-D-0996 for ``Technical Considerations for Medical Devices with
Physiologic Closed-Loop Control Technology.'' 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, 240-402-7500.
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
[[Page 72972]]
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 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 Medical Devices with Physiologic Closed-
Loop Control Technology'' to the Office of Policy, Center for Devices
and Radiological Health (CDRH), 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: Christopher Scully, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, Rm. 1129, Silver Spring, MD 20993-0002, 301-
796-2928.
SUPPLEMENTARY INFORMATION:
I. Background
PCLC technology can enable automation in a variety of medical
device types including infusion systems, ventilators, extracorporeal
systems, and stimulation systems. Automated adjustments of a
physiologic variable(s) through the delivery of energy or substance
(i.e., therapy), such as automated fluid resuscitation, ventilation/
oxygenation, and anesthesia delivery, are emerging applications for the
critical and emergency care environments. PCLC devices may benefit the
patient by facilitating safe and effective, consistent, and timely
delivery of appropriate therapy with improved and distraction-free
performance. However, introducing automation and reducing clinician
involvement can incur new types of hazards which may render the medical
device unsafe if not properly designed or evaluated. This guidance
provides technical considerations for PCLC technology during device
development to support the safe and effective design and evaluation of
PCLC medical devices.
CDRH held a public workshop entitled ``Physiological Closed-Loop
Controlled Devices'' on October 13 and 14, 2015,\1\ with the aim of
fostering an open discussion on design and evaluation considerations
associated with PCLC devices used in critical care environments. This
workshop provided a forum for medical device manufacturers, clinical
users, and academia to discuss technical considerations for automated
medical devices with PCLC technology. The feedback and recommendations
provided at the meeting were incorporated in this draft guidance.
---------------------------------------------------------------------------
\1\ See https://wayback.archive-it.org/7993/20170112084803/http:/www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm457581.htm.
---------------------------------------------------------------------------
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 Medical Devices with Physiologic Closed-Loop Control
Technology. 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.
II. 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 or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Technical Considerations for Medical
Devices with Physiologic Closed-Loop Control Technology'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1500085 and
complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does 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 this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
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.
814, subparts A through E......... Premarket approval.. 0910-0231
814, subpart H.................... Humanitarian Device 0910-0332
Exemption.
812............................... Investigational 0910-0078
Device Exemption.
``De Novo Classification Process De Novo 0910-0844
(Evaluation of Automatic Class classification
III Designation)''. process.
``Requests for Feedback on Medical Q-submissions....... 0910-0756
Device Submissions: The Pre-
Submission Program and Meetings
with Food and Drug Administration
Staff''.
800, 801, and 809................. Medical Device 0910-0485
Labeling
Regulations.
[[Page 72973]]
803............................... Medical Devices; 0910-0437
Medical Device
Reporting;
Manufacturer
reporting, importer
reporting, user
facility reporting,
distributor
reporting.
820............................... Current Good 0910-0073
Manufacturing
Practice (CGMP);
Quality System (QS)
Regulation.
58................................ Good Laboratory 0910-0119
Practice (GLP)
Regulations for
Nonclinical
Laboratory Studies.
------------------------------------------------------------------------
Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27825 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P
