Notice2021-27825
Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
December 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology."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 This draft guidance provides technical considerations for PCLC technology in order to promote development and availability of safe and effective PCLC medical devices. This draft guidance is not final nor is it in effect at this time.
Full Text
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<title>Federal Register, Volume 86 Issue 244 (Thursday, December 23, 2021)</title>
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[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72971-72973]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27825]
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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Closed-Loop Control Technology; Draft Guidance for Industry and Food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.
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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the availability of the draft guidance entitled ``Technical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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
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\1\ See <a href="http://wayback.archive-it.org/7993/20170112084803/http:/www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm457581.htm">http://wayback.archive-it.org/7993/20170112084803/http:/www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm457581.htm</a>.
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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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#236067716b0e64564a47424d4046634547420d4b4b500d444c55"><span class="__cf_email__" data-cfemail="044740564c2943716d60656a6761446260652a6c6c772a636b72">[email protected]</span></a> 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:
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OMB Control
21 CFR part; guidance; or FDA form Topic No.
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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.
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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
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