Notice2023-21412
Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
September 29, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final 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 guidance provides technical considerations for PCLC technology in order to promote development and availability of safe and effective PCLC medical devices.
Full Text
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<title>Federal Register, Volume 88 Issue 188 (Friday, September 29, 2023)</title>
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[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67313-67315]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21412]
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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; 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 a final 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 guidance provides
technical considerations for PCLC technology in order to promote
development and availability of safe and effective PCLC medical
devices.
DATES: The announcement of the guidance is published in the Federal
Register on September 29, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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 in the body of
your comments and you
[[Page 67314]]
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 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. 1130, 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 or removal of energy or
article (e.g., drugs,\1\ or liquid or gas regulated as a medical
device), 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 or
removal of energy or article. 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.
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\1\ The term drug as used in this guidance refers to both human
drugs and biological products unless otherwise
specified.
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CDRH held a public workshop entitled ``Physiological Closed-Loop
Controlled Devices'' on October 13 and 14, 2015 \2\ 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 guidance.
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\2\ 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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A notice of availability of the draft guidance appeared in the
Federal Register of December 23, 2021 (86 FR 72971). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including clarification that the scope of the guidance
is limited to recommendations regarding PCLC aspects of a device,
adding potential benefits of PCLC devices, adding references to
applicable guidance documents and standards, adding more examples of
PCLC device functions, revising technical considerations in PCLC device
design, and addressing device interoperability.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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 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#1b585f4953365c6e727f7a75787e5b7d7f7a35737368357c746d"><span class="__cf_email__" data-cfemail="3f7c7b6d7712784a565b5e515c5a7f595b5e1157574c11585049">[email protected]</span></a> to receive an electronic
copy of the document. Please use the document number GUI01500085 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:
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OMB control
21 CFR part or guidance Topic No.
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807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
814, subpart H................. Humanitarian Use 0910-0332
Devices; Humanitarian
Device Exemption.
812............................ Investigational Device 0910-0078
Exemption.
860, subpart D................. De Novo classification 0910-0844
process.
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``Requests for Feedback and Q-submissions and Early 0910-0756
Meetings for Medical Device Payor Feedback Request
Submissions: The Q-Submission Programs for Medical
Program''. Devices.
800, 801, 809, and 830......... Medical Device Labeling 0910-0485
Regulations; Unique
Device Identification.
803............................ Medical Device 0910-0437
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: September 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21412 Filed 9-28-23; 8:45 am]
BILLING CODE 4164-01-P
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