83 FR 9857 - Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing in Adults; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 46 (March 8, 2018)

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing in Adults.'' The topic to be discussed is the appropriate design of clinical studies to evaluate devices including digital health technologies intended for the diagnosis, monitoring, or treatment of sleep disordered breathing (SDB) in adults. Study design considerations to be discussed include definitions for SDB conditions, inclusion/exclusion criteria for studies of these conditions, use of SDB assessment technologies, controls, and study endpoints.

[Federal Register Volume 83, Number 46 (Thursday, March 8, 2018)]
[Notices]
[Pages 9857-9859]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04629]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0756]


Study Design Considerations for Devices Including Digital Health 
Technologies for Sleep Disordered Breathing in Adults; Public Workshop; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Study Design 
Considerations for Devices including Digital Health Technologies for 
Sleep Disordered Breathing in Adults.'' The topic to be discussed is 
the appropriate design of clinical studies to evaluate devices 
including digital health technologies intended for the diagnosis, 
monitoring, or treatment of sleep disordered breathing (SDB) in adults. 
Study design considerations to be discussed include definitions for SDB 
conditions, inclusion/exclusion criteria for studies of these 
conditions, use of SDB assessment technologies, controls, and study 
endpoints.

DATES: The public workshop will be held on April 16, 2018, from 8 a.m. 
to 5 p.m. Submit either electronic or written comments on this public 
workshop by April 30, 2018. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

[[Page 9858]]

    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before April 30, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end April 30, 2018. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.

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-2018-N-0756 for ``Study Design Considerations for Devices including 
Digital Health Technologies for Sleep Disordered Breathing in Adults; 
Public Workshop; Request for Comments.'' Received comments, those filed 
in a timely manner (see ADDRESSES), 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.
     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.thefederalregister.org/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Sageev George, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2443, Silver Spring, MD 20993, 301-796-6468, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Over the past several years, FDA has seen a marked increase in 
premarket submissions for devices intended for both the diagnosis and 
treatment of SDB. These include novel technologies for in-home 
assessment, intra-oral appliances, externally worn devices that 
generate increased upper airway pressures, passive implants, active 
implantable devices that stimulate the upper airway neuromusculature, 
and mobile apps for assessing and monitoring sleep. The large variety 
of technologies often poses different and challenging questions of 
safety and effectiveness and differing benefit-risk profiles for these 
devices. We have planned this workshop to bring together device 
regulators, clinical experts in sleep medicine, patients, and other 
stakeholders to discuss these challenges and potential solutions. The 
goal is to expedite innovation in SDB devices including digital health 
technologies and make sure that patients have timely access to 
reasonably safe and effective devices. To this end, we are actively 
seeking input and participation from several professional societies and 
patient advocacy groups with interests in the field of SDB.

II. Topics for Discussion at the Public Workshop

    The topics to be discussed are the appropriate design of clinical 
studies to evaluate devices and digital health technologies intended 
for the diagnosis, monitoring, or treatment of SDB in adults. Study 
design considerations to be discussed include definitions for SDB 
conditions, inclusion/exclusion criteria for studies of these 
conditions, use of SDB assessment technologies (e.g., polysomnography, 
home sleep studies), controls, and study endpoints.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit 
FDA's Medical Devices News & Events--Workshops & Conferences calendar 
at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by April 9, 2018, by 4 p.m. Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. 
Registrants will receive

[[Page 9859]]

confirmation when they have been accepted. If time and space permit, 
onsite registration on the day of the public workshop will be provided 
beginning at 7:30 a.m. We will let registrants know if registration 
closes before the day of the public workshop.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, 
Silver Spring, MD 20993-0002, 301-796-5661, email: 
[email protected], no later than April 9, 2018.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. The webcast link will be available on the registration 
web page after April 9, 2018. Organizations are requested to register 
all participants, but to view using one connection per location.
    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 https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available 
approximately 45 days after the public workshop on the internet at 
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

    Dated: March 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04629 Filed 3-7-18; 8:45 am]
 BILLING CODE 4164-01-P