[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67313-67315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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 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: 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 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 http://wayback.archive-it.org/7993/20170112084803/http:/www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm457581.htm.
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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 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 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:

------------------------------------------------------------------------
                                                            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.

[[Page 67315]]

 
``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