[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49248-49250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2734]


Physiological Closed-Loop Controlled Devices; Public Workshop; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Physiological Closed-Loop 
Controlled (PCLC) Devices.'' The topic to be discussed is challenges 
related to the design, development, and evaluation of critical care 
PCLC devices. FDA considers PCLC devices an emerging technology and 
aims to hold a workshop focusing on design, development and performance 
evaluation of PCLC systems intended for use in critical care 
environments. Such devices include closed-loop anesthetic delivery, 
closed-loop vasoactive drug and fluid delivery, and closed-loop 
mechanical ventilation.
    Dates and Times: The public workshop will be held on October 13 and 
14, 2015, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, Rm. 
1503 (The Great Room), Silver Spring, MD 20993.
    Entrance for the public meeting participants (non-FDA employees) is 
through Building 1 where routine security check procedures will be 
performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Persons: Bahram Parvinian, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2534, Silver Spring, MD 20993, 301-796-6445, email: 
[email protected]; and Allison Kumar, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5402, Silver Spring, MD 20993, 301-796-6369, email: 
[email protected].
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by 4 p.m., October 1, 2015. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permits, onsite registration on the day 
of the public workshop will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Office of Communication and Education (OCE), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 301-796-5661, email: [email protected] no later 
than September 29, 2015.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this meeting/public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone 
number. Those without Internet access should contact Susan Monahan to 
register. Registrants will receive confirmation after they have been 
accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by 4 p.m., October 1, 2015. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after October 7, 2015. If you have never attended a 
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a 
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has

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verified the Web site addresses in this document, but FDA is not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)
    Requests for Oral Presentations: This public workshop includes a 
public comment session and topic-focused sessions. During online 
registration you may indicate if you wish to present during a public 
comment session or participate in a specific session, and which topics 
you wish to address. FDA has included general topics in this document. 
FDA will do its best to accommodate requests to make public comments. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations, and request time for a 
joint presentation, or submit requests for designated representatives 
to participate in the focused sessions. Following the close of 
registration, FDA will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin, 
and will select and notify participants by September 15, 2015. All 
requests to make oral presentations must be received by September 1, 
2015. If selected for presentation, any presentation materials must be 
emailed to Bahram Parvinian and Allison Kumar (see Contact Persons) no 
later than October 1, 2015. No commercial or promotional material will 
be permitted to be presented or distributed at the public workshop.
    Comments: FDA is holding this public workshop to obtain information 
on challenges related to the design, development, and evaluation of 
critical care PCLC devices. In order to permit the widest possible 
opportunity to obtain public comment, FDA is soliciting either 
electronic or written comments on all aspects of the public workshop 
topics. The deadline for submitting comments related to this public 
workshop is September 1, 2015.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II of this document, please identify 
the question you are addressing. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see Comments). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. The address of 
the Division of Freedom of Information is available on the Agency's Web 
site at http://www.fda.gov. A link to the transcripts will also be 
available approximately 45 days after the public workshop on the 
Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the 
posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    PCLC medical devices are an emerging technology in the intensive 
care and emergency medicine settings that provides autonomous therapy 
adjustments to manipulate a physiological variable. For example, a 
closed-loop oxygen delivery device may automatically adjust the 
fraction of inspired oxygen when an individual's oxygen saturation 
level drifts too high or too low. PCLCs could benefit patients and 
practitioners by automating a number of tasks including adjustments to 
mechanical ventilation, anesthetic delivery, and fluid resuscitation. 
These devices may provide practitioners more resources to consider the 
course of treatment for an individual patient and improve resource 
allocation during times of medical surge (e.g., from mass casualty 
incidents). PCLC medical devices may also allow additional therapeutic 
and diagnostic capabilities by providing precise control of 
physiological variables by continuous manipulation of therapy that is 
impractical for a medical practitioner to perform.
    Recent advances in medical device technology and control systems 
science have increased the development of PCLC medical devices. PCLCs 
shift specific assignments of data interpretation and therapy 
manipulation from a practitioner to a medical device. This may or may 
not introduce new risks to patients, but could introduce new medical 
device hazards that, considered during design and development, can be 
mitigated throughout the device life-cycle. Addressing technical and 
clinical challenges for a PCLC medical device to be robust, stable, and 
effective in its environment of use will ensure patient safety and 
promote innovation and development of PCLC medical devices.
    This workshop seeks to involve industry, academia, medical 
societies, patient groups, standard bodies, and other relevant 
stakeholders in addressing the challenges in the development and 
implementation of PCLC medical devices in critical care environments. 
Participants in the workshop will include scientists and engineers 
developing PCLC medical devices, as well as end users including 
physicians, nurses, and patients. The intent of the workshop is to 
discuss benefit-risk considerations, design strategies, pre-clinical 
testing, and clinical evaluation for specific product areas of PCLC 
medical devices. Ideas generated during this workshop may facilitate 
development of new draft guidances and/or standards for PCLC medical 
devices.

II. Topics for Discussion at the Public Workshop

    This workshop is aimed to address the scientific, clinical and 
regulatory considerations associated with these devices, including, but 
not limited to, the following topic areas:
    1. Benefit-risk considerations at varying levels of closed-loop 
medical device autonomy
    2. Challenges related to the design and development of critical 
care PCLC devices
    a. System performance analysis for different controller types 
(e.g., rule based/knowledge based, proportional-integral derivative, 
fuzz logic, adaptive predictive, neural networks)
    b. Fault detection and fallback modes
    c. User interfaces and operational transparency
    3. Knowledge gap between clinicians and system engineers
    a. Clinician involvement in system design
    b. Control system terminology
    4. Pre-clinical evaluation
    a. Evidence needed to demonstrate a stable and robust controller
    b. Use of computer simulations including verification, validation 
and uncertainty quantification of physiological models used for design 
and evaluation of PCLC systems.
    c. Real time bench testing
    5. Clinical evaluation (e.g., study design, clinical endpoints, 
outside the U.S. data)
    a. Clinical validity of sensors
    b. Patient populations
    c. Environments of use
    d. User related level of expertise.

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    6. Human factors of autonomous medical devices (e.g., usability, 
training, clinical decisionmaking)

    Dated: August 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20127 Filed 8-14-15; 8:45 am]
 BILLING CODE 4164-01-P